Clinical Trial News

Abstracts by Tom Swartz

Chemotherapy Before Surgery to Treat Malignant Peripheral Nerve Sheath Tumor

This Phase II trial is currently recruiting patients. This study will examine the response to treatment with chemotherapy followed by surgery to remove malignant peripheral nerve sheath tumors (MPNSTs) in patients with or without neurofibromatosis type 1 (NFI). Patients of any age with one or more MPNSTs who have not received chemotherapy or radiation therapy for the MPNST and who either have not had prior surgery or who still have tumor after surgery may be eligible for this study. Patients with NF1 may have received prior chemotherapy, excluding ifosfamide, doxorubicin, or etoposide, to treat plexiform neurofibromas. Candidates are screened with blood and urine tests, MUGA (heart nuclear medicine test), echocardiogram (heart ultrasound), x-rays of the chest and primary tumor site, CT of the chest and MRI of the primary tumor site, biopsy (surgical removal of small piece of tumor tissue) or examination of previously obtained biopsy specimen, and positron emission tomography (nuclear medicine test, see below) in patients 5 years old or older. Chemotherapy is given in 21 days cycles, with the drugs given on days 1 through 5, followed by a 14-day recovery period. Doxorubicin and ifosfamide are given on days 1 through 5 of cycles 1 and 2, and then ifosfamide and etoposide are given on days 1 through 5 of cycles 3 and 4. Patients receive filgrastim or neulasta 24 to 36 hours after the last dose of each cycle to boost white blood cell count. Treatment may continue for up to 8 cycles in patients whose tumor has not grown by the end of the first four cycles. Surgery or radiation, or both, for local control of the MPNST will be performed at the end of cycle 4. If surgery is performed, a portion of the removed tumor is studied for markers for MPNSTs, gene changes and the effect of chemotherapy on the tumor cells. After chemotherapy is completed, patients are monitored with examinations, blood tests and scans for long-term side effects of treatments and for any sign of the cancer first monthly, then every 3 months, then every 6 months, and then every year until 5 years from finishing treatment. The total expected enrollment is 74 patients. This trial is taking place at the National Cancer Institute, Bethesda, Maryland.

Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults with Refractory Solid Tumors

This Phase II trial is currently recruiting patients. Ixabepilone (BMS-247550) is a semi-synthetic analog of the natural product epothilone B. The epothilones are a novel class of non-taxane microtubule-stabilizing agents obtained from the fermentation of the cellulose degrading myxobacteria, Sorangium cellulosum. Ixabepilone is active against preclinical cancer models that are naturally insensitive to paclitaxel or have developed resistance to paclitaxel, both in-vitro and in-vivo. The National Cancer Institute (NCI) Pediatric Oncology Branch is conducting a phase I trial of Ixabepilone on a daily x 5 consecutive day schedule. The drug has been well tolerated in children at doses of up to 8 mg/m(2)/d. This Phase II trial is designed to establish the objective response rate using RECIST criteria of Ixabepilone in solid tumors occurring in pediatric and young adult patients. Patients will be accrued in one of six disease strata: osteosarcoma, Ewing's sarcoma/Peripheral neuroectodermal tumor (PNETs), rhabdomyosarcoma, synovial sarcoma and malignant peripheral nerve sheath tumor (MPNSTs), neuroblastoma, or Wilms tumor. Patients are eligible if they have measurable disease and have not previously received taxanes. Patients must be greater than or equal to 12 months old at trial entry. Patients with sarcoma must have been less than or equal to 35 years old at original diagnosis; patients with Wilms tumor or neuroblastoma must have been less than or equal to 21 years old at original diagnosis. The treatment outline is as follows. Ixabepilone will be administered as a one-hour infusion on Days 1 to 5 every 21 days at a dose of 8 mg/m(2)/dose. The trial will use a two-stage design targeting a response rate of 30%. Up to 20 patients will be accrued to each tumor stratum. The total expected enrollment is 120 patients. This trial is taking place at the National Cancer Institute, Bethesda, Maryland.

Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer

This Phase I trial is currently recruiting patients. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells. Thus, the purpose of this trial is to study side effects and best dose of radiolabeled monoclonal antibody therapy in treating patients with refractory, recurrent, or advanced central nervous system or leptomeningeal cancer. Patients with the following sarcomas are eligible: rhabdomyosarcoma, soft tissue sarcoma, rhabdoid tumor of the central nervous system, desmoplastic small round-cell tumor, osteosarcoma, and Ewing's family of tumors. This is a dose-escalation study. Patients receive iodine I 131 monoclonal antibody 8H9 (^131I MOAB 8H9) intrathecally on day 1. Treatment repeats every 4 weeks for up to 2 courses (total of 2 injections) in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ^131I MOAB 8H9 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 3-30 patients will be accrued for this study within 2-3 years. Patients of any age are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York, NY.

FR901228 in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma

This Phase II trial is currently recruiting patients. FR901228 is a type of depsipeptide and belongs to the family of drugs called histone deacetylase inhibitors. Depsipeptide binds to and inhibits histone deacetylase, thereby affecting the regulation of gene expression and inducing cell differentiation, cell cycle arrest, and apoptosis. This agent also inhibits hypoxia-induced angiogenesis and depletes several HSP90-dependent oncoproteins. The purpose of this trial is to study how well FR901228 works in treating patients with metastatic or unresectable soft tissue sarcoma. Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. After completion of study treatment, patients are followed every 2 months. A total of 18-36 patients will be accrued for this study within approximately 1 year. Patients 18 years of age and older are eligible. This study is taking place at centers in Arizona, California, Georgia, Illinois, Kentucky, North Carolina, Ohio, South Carolina, and Virginia.

Safety, Tolerability and Maximum Tolerated Dose of Oral AP23573 in Combination With Doxorubicin

This Phase I trial is currently recruiting patients. This study is designed to determine the safety, tolerability and maximum tolerated dose of Oral AP23573 in combination with Doxorubicin. Sarcoma patients 18 years of age and older are eligible. The treatment outline is not listed on the site. The total expected enrollment is 60 patients; the study started February 2006. The study is taking place at centers in California, Michigan, and Pennsylvania. For further details contact: Hanne Harbison 215-829-6712.

A Study to Provide Access to Trabectedin in Patients With Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment

This Phase III trial is currently recruiting patients. The purpose of this study is to provide compassionate use access to treatment with trabectedin (ET-743) before the drug is commercially available and reimbursable to patients who previously received treatment for soft tissue sarcoma. 1.5 mg/m2 of trabectedin reconstituted and diluted to 500 mL volume will be administered by central venous line over 24 hours at start of each 21-day treatment cycle. 20 mg of dexamethasone, an anti-inflammatory agent, will also be administered by vein 30 minutes before each trabectedin dose. The number of cycles will be response dependent. Sarcoma patients 18 years of age and older who have relapsed or have progressive disease following standard of care treatment prior to enrollment, or who are intolerant to standard of care treatment due to safety issues, are eligible. The total expected enrollment is 200 patients. The trial is taking place at centers in California, Idaho, Illinois, Kentucky, Massachusetts, New Jersey, Oregon, Pennsylvania, South Carolina, and Texas.

GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors

This Phase I trial is currently recruiting patients. GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by making tumor cells more sensitive to gemcitabine. The purpose of this trial is to study the side effects and best dose of GTI-2040 and gemcitabine in treating patients with metastatic or unresectable solid tumors. Patients receive GTI-2040 IV continuously on days 2-16 of course 1 and on days 1-16 of all subsequent courses and gemcitabine IV over 30 minutes on days 1, 8, and 15 of course 1 and on days 2, 9, and 16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of GTI-2040 and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose. Approximately 18-40 patients will be accrued for this study within 6-20 months. Patients 18 years of age and older are eligible. This trial is taking place at the Cancer Therapy and Research Center, San Antonio, Texas, and the Veterans Affairs Medical Center also of San Antonio, Texas.

GW786034 in Treating Patients With Relapsed or Metastatic Soft Tissue Sarcoma

This Phase II trial is currently recruiting patients. GW786034 is a multifunctional antiangiogenic agent derived from shark cartilage with potential antineoplastic activity. Neovastat competitively inhibits the binding of pro-angiogenic vascular endothelial growth factor (VEGF) to its cell receptor, thereby inhibiting endothelial cell proliferation. This agent also inhibits matrix metalloproteinases (MMPs), stimulates tissue plasminogen activator (tPA), and activates caspase-mediated apoptotic pathways in endothelial cells. GW786034 may stop the growth of soft tissue sarcoma by blocking blood flow to the tumor and by blocking some of the enzymes needed for tumor cell growth. The purpose of this trial is to study how well GW786034 works in treating patients with relapsed or metastatic soft tissue sarcoma. This is an open-label, nonrandomized, multicenter study. Patients are stratified according to tumor type (leiomyosarcoma vs. adipocytic tumor vs. synovial sarcoma vs. other soft tissue sarcoma). Patients receive oral GW786034 once daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression. After completing study treatment, patients are followed at 4 weeks and then every 3 months thereafter. A total of 148 patients (37 per stratum) will be accrued for this study. Soft tissue sarcoma patients 21 years of age and older are eligible. The following tumor types are excluded from this study: embryonal rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewing tumors/primitive neuroectodermal tumors, gastrointestinal stromal tumors, dermofibromatosis sarcoma protuberans, inflammatory myofibroblastic sarcoma, neuroblastoma, malignant mesothelioma, mixed mesodermal tumors of the uterus. This trial is taking place at Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam, Netherlands.

GW786034 In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma

This Phase II trial is currently recruiting patients. The purpose of this trial is to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma. This is a randomized, multicenter study. Patients are stratified according to risk status and window therapy eligibility (unfavorable risk and eligible vs. unfavorable risk and ineligible vs. favorable risk). The treatment outline is as follows:

	Patients are stratified according to prior topotecan (yes vs. no). These patients are randomized to 1 of 2 treatment arms.
	Arm I: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
	Arm II: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
	Patients in both arms with partial response (PR) or complete response (CR) receive 5 additional courses of irinotecan and vincristine on the previous schedule. In addition, patients with PR or CR also receive cyclophosphamide/doxorubicin (CD) and ifosfamide/etoposide (IE) chemotherapy.
	CD/IE Chemotherapy: Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 7, 16, 28, 37, and 40. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 10, 19, 22, 31, and 43. Treatment continues in the absence of disease progression or unacceptable toxicity.
	Patients with no response or progressive disease on arm I or II proceed to tirapazamine/cyclophosphamide/doxorubicin (TCD) and ifosfamide/etoposide (IE) chemotherapy.
	TCD/IE Chemotherapy: Patients receive tirapazamine IV over 2 hours, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-30 minutes on day 1 of weeks 7, 10, 16, 25, and 34. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 13, 19, 22, 28, 31, and 37.
	Patients with unfavorable risk and ineligible for window therapy: Patients receive tirapazamine IV over 2 hours, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-30 minutes on day 1 of weeks 1, 4, 10, 19, and 28. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7, 13, 16, 22, 25, and 31. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) beginning 1 day after each course of chemotherapy and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
	Patients with favorable risk: Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 1, 4, 10, 19, and 28. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7, 13, 16, 22, 25, and 31. Patients also receive G-CSF or GM-CSF SC beginning 1 day after each course of chemotherapy and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 4 months for 2 years, and then annually thereafter. A total of 102-120 patients with unfavorable-risk disease (51 per treatment arm) will be accrued for this study within 2.5-3 years. A total of 20-30 patients with favorable-risk disease will be accrued for this study. Patients up to 20 years of age are eligible. The trial is taking place at centers in Alabama, Arizona, Arkansas, California, Connecticut, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, West Virginia, Wisconsin, Australia, Canada, and Puerto Rico.

A Study of Anti-CTLA4 Antibody in People with Advanced Synovial Sarcoma

This Phase II is currently recruiting patients. The investigators of this study will try to exploit some of the proteins made by synovial sarcoma (cancer-germ cell or cancer-testis antigens) as targets for the immune system. Specifically, they will investigate if immune-based therapy with anti-CTLA4 antibody once every 4 weeks for three treatments will activate the immune system enough to attack recurrent synovial sarcoma. In this study the tumor itself will serve as the "vaccine" or source of protein to activate tumor-fighting T cells with the anti-CTLA4. Anti-CTLA4 takes the brakes off the immune system to allow otherwise hidden immune responses to become more active. In so doing, there could be other side effects, such as immune system attacks against the normal organs of the body. Thus, the investigators will follow both the anti-tumor immune responses with frequent blood tests and follow and treat side effects people develop on this study to determine if anti-CTLA4 is worth pursuing in a larger number of patients with synovial sarcoma or other sarcomas. Patients 18 years of age and older are eligible. The total expected enrollment is 17 patients. The trial started July 2005 and it is expected to be completed in March 2007. This study is taking place at Memorial Sloan-Kettering Cancer Center, New York.

Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery

This Phase II trial is currently recruiting patients. The purpose of this trial is to study how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery. Patients receive paclitaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses. A total of 15-30 patients will be accrued for this study. Patients 18 to 70 years of age are eligible. This trial is taking place at several centers in France.

Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

This Phase III trial is currently recruiting patients. The purpose of this trial is to compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs. without ifosfamide and pegfilgrastim as first-line therapy. Patients are stratified according to WHO performance status (0 vs. 1), age group (less than 50 years of age vs. 50 years of age and over), presence of liver metastases (yes vs. no), histological grade (2 vs. 3), and participating center. Patients are randomized to 1 of 2 treatment arms as follows:

	Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3)
	Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. The following sarcomas are eligible: malignant fibrous histiocytoma, myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma, pleomorphic rhabdomyosarcoma, synovial sarcoma, myxofibrosarcoma (intermediate and high-grade), fibrosarcoma, leiomyosarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, epithelioid sarcoma, alveolar rhabdomyosarcoma, unclassifiable sarcoma, not otherwise specified. A total of 450 patients will be accrued for this study within 4 years (study start 5/2003). Patients 18 to 60 years of age are eligible. This trial is taking place at centers in Austria, Belgium, Denmark, France, Germany, the Netherlands, Slovakia, Spain, and the United Kingdom.

Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma

This phase I/II trial is currently recruiting patients. Nelfinavir mesylate is a protease inhibitor which may help prevent cancer cells from spreading. The purpose of this trial is to study the side effects and best dose of nelfinavir mesylate and to see how well it works in treating patients with recurrent, metastatic, or unresectable liposarcoma. This is a phase I dose-escalation study followed by a phase II study. In the Phase I part of the study, patients receive oral nelfinavir mesylate twice daily in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of nelfinavir mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. In the Phase II part of the study, patients receive nelfinavir mesylate as in phase I at the MTD. A total of 40 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the City of Hope Comprehensive Cancer Center, Duarte, California.

Phase II Study of Vinorelbine + Cyclofosfamide Among Patients Reached of Refractory Tumors or in Relapse

This phase II trial is currently recruiting patients. The purpose of this study is to determine the antitumor activity of vinorelbine + cyclofosfamide in patients with a refractory tumor or in relapse in rhabdomyosarcomas and other soft part tissue tumors, Ewing’s tumors, osteosarcomas, neuroblastomas or medulloblastomas. The total expected enrollment is 210 patients (the study started in June 2003). Patients 12 months to 25 years of age are eligible. This study is taking place at the Institut Gustave-Roussy, Villejuif, France.

Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

This Phase III trial is currently recruiting patients. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma. Thus, the purpose of this trial is to study combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. The treatment outline is as follows:

	Patients receive doxorubicin IV continuously over 48 hours on days 1-2 and cisplatin IV over 4 hours on days 1 and 2 in weeks 1 and 6. Patients also receive high-dose methotrexate (MTX)* IV over 4 hours on day 1 in weeks 4, 5, 9, and 10. Patients then proceed to surgery. NOTE: *Patients must receive ≥ 2 but ≤ 6 doses of high-dose MTX.
	Surgery: Patients undergo amputation or limb salvage surgery in week 11. Tumor tissue is evaluated for histological response to induction therapy. Patients whose tumor is not amenable to macroscopically complete surgical resection undergo radiotherapy and/or other investigational therapy off study. Patients who undergo macroscopically complete surgical resection of the primary tumor or metastases AND who have no disease progression or unacceptable toxicity proceed to maintenance therapy.
	Patients are assigned to 1 of 2 groups according to histological response (good [< 10% viable tumor] vs. poor [≥ 10% viable tumor]). Patients in each group are stratified according to site of primary tumor and presence of metastases.
	Patients are randomized to 1 of 2 treatment arms within 35 days after surgery.
	Arm I (MAP; weeks 12-29): Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.
	Arm II (MAPifn; weeks 12-104): Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I . Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.
	Patients are randomized to 1 of 2 treatment arms within 35 days after surgery.
	Arm I (MAP; weeks 12-29): Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.
	Arm II (MAPIE; weeks 12-40): Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.

In both groups, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 1½-3 months for 2 years, every 2-4 months for 2 years, every 6 months for 6 years, and then every 6-12 months thereafter. A total of 1,400 patients (630 good responders and 770 poor responders) will be accrued for this study within 4 years. Patients between 5 and 40 years of age are eligible. Patients who have received prior treatment for osteosarcoma are not eligible. This trial is taking place at centers in Canada, Germany, Norway, and the United Kingdom.

A phase II trial to assess the activity of Gemcitabine and Docetaxel as first line chemotherapy treatment in patients with unresectable leiomyosarcoma

This phase II trial is currently recruiting patients. It is open to patients that have histologically proven leiomyosarcoma of the uterus or other sites considered unresectable for cure. No previous chemotherapy is allowed, but patients may have received prior radiation provided it is completed >6 weeks prior to inclusion. It is a study of gemcitabine and docetaxel as a first line treatment. A total of 44 patients will be recruited. The trial is taking place in the United Kingdom. For further details, contact Jennifer Morrison.

Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma

This Phase II trial is currently recruiting patients. Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane are widely used drugs in the treatment of sarcomas. ImmTher is an investigational agent which stimulates the body's white blood cells to attack and kill tumor cells. The goal of this study is to see if treatment with vincristine, doxorubicin, cyclophosphamide and dexrazoxane (VACdxr) given in high doses with or without ImmTher will help patients with Ewing's sarcoma live longer. The safety of these treatments will also be studied. The total expected enrollment is 104 patients. Patients between 3 and 60 years of age are eligible. This trial is taking place at University of Texas M.D. Anderson Cancer Center, Houston, Texas.

Phase III Randomized Study of Doxorubicin With Versus Without Ifosfamide and Pegfilgrastim in Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

This Phase III trial is currently recruiting patients. The purpose of this trial is to compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs. without ifosfamide and pegfilgrastim as first-line therapy. Patients are stratified according to WHO performance status (0 vs. 1), age group (less than 50 years of age vs. 50 years of age and over), presence of liver metastases (yes vs. no), histological grade (2 vs. 3), and participating center. Patients are randomized to 1 of 2 treatment arms as follows:

	Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3)
	Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.

Bendamustin Hydrochloride in Patients with Soft Tissue Sarcoma

This Phase II trial is currently recruiting patients. Bendamustin is a bifunctional alkylating agent with low toxicity that produces both single and double strand breaks of DNA. It has show anti-tumor activity against Hodgkin’s and non-Hodgkin’s lymphomas, multiple myeloma, and chronic lymphatic leukemia. The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-based chemotherapy and to assess its toxicity. Patients 18 years of age and older are eligible. This trial is taking place at Medical center II, University of Tuebingen, Tuebingen, Germany.

ZD1839 and Oral Irinotecan in Treating Young Patients with Refractory Solid Tumors

This Phase I trial is currently recruiting patients. The purpose of this trial is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose. The total expected enrollment is 30 patients. Patients up to 21 years of age are eligible. This trial is taking place at St. Jude Children's Research Hospital, Memphis, Tennessee.

Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma

This Phase II trial is currently recruiting patients. Pemetrexed disodium (Alimta) is a potent new antifolate which inhibits many folate-dependent reactions that are essential for cell proliferation. Its primary target is thymidylate synthase but it also inhibits folate-dependent enzymes involved in purine synthesis. Cells that are resistant to antifolates are generally less resistant to pemetrexed, irrespective of the mechanism of resistance. Pemetrexed has shown good activity in preclinical models with human tumor cells and xenografts. In the majority of clinical trials of pemetrexed, the dose-limiting toxic effect is neutropenia; other side-effects are mostly gastrointestinal. Preclinical studies indicate that the toxic effects of pemetrexed can be reduced by dietary folate, resulting in an improved therapeutic index. Low folate status is also associated with higher levels of toxicity in patients. As a single agent pemetrexed has shown good activity against non-small-cell lung cancer, squamous-cell carcinoma of head and neck, colon cancer, and breast cancer, and it appears to be particularly active in combination with cisplatin against non-small-cell lung cancer and mesothelioma. The purpose of this trial is to study how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma. Patients are stratified according to prior chemotherapy (yes vs. no). The treatment outline is as follows. Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity (NOTE: *The duration of course 1 is 28 days; the duration of all subsequent courses is 21 days). Beginning 7 days before the first dose of pemetrexed disodium and continuing until 21 days after the completion of pemetrexed disodium, patients receive cyanocobalamin (vitamin B-12) intramuscularly once every 63 days and oral folic acid once daily. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients achieving a confirmed partial response (PR) that is resectable, proceed to surgical resection and then receive 2 additional courses of therapy after recovering from surgery. Patients achieving a confirmed PR that is not resectable continue treatment in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years. A total of 40-75 patients (20-40 in the previously treated stratum and 20-35 in the previously untreated stratum) will be accrued for this study within 20-37.5 months. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Illinois, Kansas, Missouri, Montana, North Carolina, South Carolina, and Wyoming.

Study of Oral AP23573 to Treat Patients with Refractory or Advanced Malignancies

This Phase I trial is currently recruiting patients. AP23573, being developed by Ariad Pharmaceuticals, Inc., is a mTOR inhibitor that starves cancer cells and shrinks tumors by regulating the response of tumor cells to nutrients and growth factors and by controlling tumor blood supply and angiogenesis through effects on vascular endothelial growth factor (VEGF) in tumor and endothelial cells. AP23573 is currently being studied in phase I and phase II clinical trials in patients with advanced cancers. Thus far, these trials have demonstrated that AP23573 has a favorable safety profile and possesses anticancer activity when administered as a 30-minute intravenous (IV) infusion daily x 5 every-two-weeks or on a weekly schedule. The primary objective of this current phase I trial, however, is to study the safety and tolerability of an orally administered dosage form of AP23573. This will be accomplished by an ascending dose study of 3 dosage regimens in patients with unresectable or metastatic cancer that is refractory to standard therapies. Patients 18 years of age and older are eligible. The expected total enrollment is 144 patients. This trial is taking place at UCLA Clinical Research Unit, Los Angeles, California, the Cancer Therapy Research Center, San Antonio, Texas, and the Cancer Institute of New Jersey, New Brunswick, New Jersey.

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors

This Phase I study is currently recruiting patients. The purpose of this clinical trial is to study the effectiveness of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in treating young patients who have recurrent or refractory leukemia or selected solid tumors, including rhabdomyosarcoma, Ewing’s sarcoma, and osteosarcoma. Patients receive 17-AAG IV over 1 hour on days 1, 4, 8, and 11 (for patients with solid tumors) OR days 1, 4, 8, 11, 14, and 18 (for patients with leukemia). Courses for all patients repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 15 patients are treated at the MTD. Patients are followed for 30 days. A total of 70 patients (35 per stratum) will be accrued for this study within 23.3-35 months. Patients up to 21 years of age eligible. This study is being conducted at cancer centers in Arizona, Colorado, Florida, Georgia, Maryland, New York, Tennessee, and Texas.

17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects and best dose of giving 17-AAG together with bortezomib in treating patients with advanced solid tumors or lymphomas. This is a dose-escalation study. Patients receive 17-AAG IV over 1 hour and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG and bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 12 additional patients (6 patients with solid tumors and 6 patients with lymphoma) are treated as above* at the MTD. NOTE: *Bortezomib is not administered on day 1 of course 1 only. Patients are followed at 3 months. A total of 3-42 patients (3-36 with solid tumors and 6 with lymphoma) will be accrued for this study within 10.3 months-3.5 years. Patients 18 years of age and older are eligible. This trial is taking place at the Warren Grant Magnuson Clinical Center, Bethesda, Maryland and the Mayo Clinic Cancer Center, Rochester, Minnesota.

17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor

This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when given together with paclitaxel in treating patients with metastatic or unresectable solid tumor. This is a dose-escalation study of 17-AAG. Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. NOTE: *17-AAG is not administered on day 1 of course 1. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6-12 patients are treated at the recommended phase II dose. A total of 6-35 patients will be accrued for this study within 2-11.7 months. Patients 18 years of age and older are eligible. This trial is taking place at the Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio and the Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.

Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects, best way to give, and the best dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when given together with gemcitabine and/or cisplatin in treating patients with advanced solid tumors. This is a dose-escalation, cohort study of 17-AAG. Patients are assigned to 1 of 3 treatment cohorts as follows: (Note: Cohort A closed to accrual as of 3/2/04; Cohort B closed to accrual as of 3/2/05).

	Cohort A (closed to accrual as of 3/2/04): Patients receive escalating doses of gemcitabine IV over 30 minutes, 17-AAG IV over 1 hour, and cisplatin IV over 2 hours on days 1 and 8.
	Cohort B (closed to accrual as of 3/2/05): Patients receive gemcitabine IV over 30 minutes, 17-AAG IV over 1 hour, and cisplatin IV over 2 hours on days 1 and 8.
	Cohort C: Patients receive gemcitabine** IV over 30 minutes and 17-AAG IV over 1 hour on days 2 and 9.
	Cohort D: Patients receive cisplatin** IV over 2 hours and 17-AAG IV over 1 hour on days 1 and 8.
	Cohort E: Patients receive gemcitabine*, 17-AAG, and cisplatin** as in cohort B.

NOTE: ** Gemcitabine and cisplatin dosage is constant, while 17-AAG is escalated in cohorts B, C, and D.

NOTE: *** Gemcitabine dosage is constant, 17-AAG is started at a higher dose level than all other cohorts, and cisplatin dosage is escalated in cohort E. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. In all cohorts, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 months. A total of 12 patients have been accrued for part I (cohort A closed to accrual as of 3/2/04) of this study. An additional 33-66 patients will be accrued for part II (cohorts B [closed to accrual as of 3/2/05], C, D, and E) of this study within approximately 3 years. Patients 18 years of age and older are eligible. This trial is taking place at the Mayo Clinic Cancer Center, Rochester, Minnesota.

Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

This Phase I trial is currently recruiting patients. The purpose of this trial is to study the side effects and best dose of combination chemotherapy 17-AAG and docetaxel in treating patients with metastatic or unresectable solid tumors. This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). This is a dose-escalation study of 17-AAG. Patients are assigned to 1 of 2 treatment groups as follows:

	Group 1: Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
	Group 2: Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients per group receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 20 additional patients (10 per group) are treated at the MTD. Approximately 33-96 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York and the Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.

Phase II Trial of Cetuximab in Patients with Metastatic and/or Locally Advanced Soft Tissue and Bony Sarcomas

This Phase II trial is currently recruiting patients. The purpose of this study is to explore how sarcomas are affected by a new medication, cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor receptor), that is found in some types of cancer. Studies have shown that this drug can be beneficial in patients with colon cancer and has been approved by the US Food and Drug Administration (FDA) for this purpose. The investigators are conducting this study to see if it is beneficial in patients with sarcoma. Patients with unresectabale or metastatic high grade soft tissue or bony sarcoma 16 years of age and older are eligible. This trial is taking place at the University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.

Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

This Phase II trial is currently recruiting patients. Intralesional resection is a less invasive type of surgery for chondrosarcoma of the bone and may have fewer side effects and improve recovery. The purpose of this trial is to study how well intralesional resection works in treating patients with low-grade chondrosarcoma of the bone. Patients undergo intralesional resection (curettage with high-speed burr). Patients then receive local adjuvant treatment comprising of liquid nitrogen, phenol, alcohol, or argon beam to the excision site. The bone cavity is then filled with either polymethyacrylate cement or a bone graft (allograft or homograft). Patients may also have a metal plate installed at the wound site. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. A total of 60 patients will be accrued for this study within 30-60 months. Patients 18 years of age and older are eligible. This trial is taking place at centers in Arkansas, Colorado, Florida, Michigan, Minnesota, Missouri, New Mexico, Oregon, Utah, and Washington.

Gemcitabine and Docetaxel to Treat Bone and Soft Tissue Cancers

This Phase II trial is currently recruiting patients. This study will examine the side effects and possible benefits of the anti-cancer drugs gemcitabine (Gemzar) and docetaxel (Taxere) in patients with bone or soft tissue cancer (sarcoma); determine how the body absorbs and eliminates the drugs; and perform genetic studies on the tumor and try to grow the tumor in the laboratory or in animals. Patients 10 years of age and older with recurrent osteosarcoma, Ewing's sarcoma, and inoperable or recurrent inoperable chondrosarcoma may be eligible for this study. Participants receive gemcitabine and docetaxel in 21-day cycles as follows: Gemcitabine is given as a 90-minute infusion on days 1 and 8 of each cycle. Docetaxel is given as a 60-minute infusion following the gemcitabine infusion on day 8 of each cycle. Filgrastim is given as an injection under the skin either: 1) daily, beginning the day after each docetaxel infusion and continuing until the bone marrow is recovered from chemotherapy (usually 7 to 10 days); or 2) in a long-acting form on the day after the docetaxel infusion. Filgrastim boosts production of blood cells that have been depleted as a result of chemotherapy. Patients are taught to self-administer the injections. Treatment will continue for a total of 14 cycles or until the patient's tumor gets larger, side effects are unacceptable, the patient decides to stop treatment, or further treatment would not be in the patient's best interest. At the end of chemotherapy, patients will be monitored for treatment side effects and disease progress, initially every 3 months and then every 6 months until 2 years from finishing treatment. The total expected enrollment is 20 patients. This trial is taking place at the National Cancer Institute, Bethesda, Maryland.

Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells. The purpose of this trial is to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma. Patients are stratified according to diagnosis (recurrent osteosarcoma vs. recurrent Ewing’s sarcoma vs. unresectable or locally recurrent chondrosarcoma). Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover. Patients may receive pegfilgrastim SC on day 9 (once per course) as an alternative to G-CSF. Treatment repeats every 21 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 1 year. A maximum of 120 patients (40 per stratum) will be accrued for this study within 17-24 months. Patients 4 years of age and older are eligible. This trial is taking place at centers in California, the District of Columbia, Georgia, Illinois, Maryland, Massachusetts, Michigan, Minnesota, New York, and Texas.

Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma

This Phase II trial is currently recruiting patients. Imatinib mesylate (Gleevec) may stop the growth of tumor cells by blocking the enzymes necessary for their growth. The purpose of this trial is to study how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma. Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks. Patients with a partial or complete response at 14 weeks undergo surgical resection if possible. If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved (section margins positive), patients continue to receive imatinib mesylate in the absence of disease progression. Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter. A total of 44 patients will be accrued for this study within 2 years. Patients 18 years of age and older are eligible. This trial is taking place at centers in Belgium and the Netherlands.

Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans (DFSP) or Transformed Fibrosarcomatous DFSP

This Phase II trial is currently recruiting patients. Imatinib mesylate (Gleevec) may stop the growth of tumor cells by blocking the enzymes necessary for their growth. The purpose of this trial is to study how well imatinib mesylate works in treating patients with locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP (a type of soft tissue sarcoma). Patients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses. Patients are followed every 6 months for 2 years and then annually for 3 years. A total of 20-40 patients will be accrued for this study within 10 months-3.4 years. Patients 18 years of age and older are eligible. This trial is taking place at centers in Arkansas, Colorado, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, Montana, North Carolina, Ohio, South Carolina, Washington, West Virginia, and Wyoming.

Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma

This Phase I trial is currently recruiting patients. The purpose of this study is to learn if a vaccine made from the patient's own tumor cells then genetically modified to secrete GM-CSF will delay or stop the growth of the tumor. It will also look at the vaccine's effects on the immune system and the side effects of giving a vaccine made from a subject's own cancer cells. The trial is open to patients with clear cell sarcoma, alveolar soft part sarcoma, pediatric renal cell carcinoma (25 years of age and younger), and children (18 years of age and younger) with stage IV melanoma. The treatment outline is as follows:

	The patient will have surgery to remove a portion of the tumor. This tumor is then brought to a special, certified laboratory where it is broken up into single cells and then washed.
	Specially trained laboratory technicians then use a method known as adenoviral mediated gene transfer, which adds a new gene to the cancer calls. This gene causes the cells to make GM-CSF, a powerful hormone that stimulates the immune system. The cells are then given enough radiation so that they will never grow, but not enough to completely destroy them, developing a vaccine.
	The patient is then injected with the vaccine on days 0, 7, 14, 28, and then every two weeks until the supply of vaccine has run out. The amount of vaccine that can be made depends upon the total amount of cells taken from the tumor. The actual injections are like childhood vaccinations that go under the skin or into muscle and a different place will be used for each injection.
	It is hoped that the cancer cells that have been made to secrete the hormone GM-CSF will cause the patients immune system to attack the cancer in other parts of the body.
	If the tumor yields enough cells, the patient will also be given an injection of non-transduced irradiated tumor cells. Non-transduced means that the gene for GM-CSF has not been added to these cells as it has for the vaccines. This is done to measure the amount of reaction of the immune system caused by the vaccine. This injection is measuring delayed type hypersensitivity, or DTH.
	The patient will be asked to undergo optional skin biopsies of the vaccine and DTH sites to see if an immune reaction is occurring at the injection sites 2 days after vaccine 1 and vaccine 5.
	The following tests and procedures will be performed through out the study: physical exam, blood samples, immune studies, vital signs and physical exam.
	At week 10 in the patients treatment, or earlier if the doctor feels it is necessary, the patient will undergo a chest, abdomen and pelvic XT scan. A brain MRI will be performed if there were any abnormalities on the first brain MRI or if any new central nervous system symptoms have developed.
	If the patient’s disease has not disappeared or if new lesions have been found after the patient receives at least six vaccines, they may have the opportunity to undergo a second course of study treatment.
	Patients may participate in this study until one of the following happens: All vaccine created from the tumor has been given to the patient; the patient's disease worsens; the patient experiences an unacceptable and/or harmful side effect; the patient becomes pregnant; the patient is unable to follow the study plan; or the patient's doctor feels it is no longer in the best interest of the patient to continue.

The total expected enrollment is 36 patients. This trial is taking place at the Dana-Farber Cancer Institute and Children's Hospital, Boston, Massachusetts.

Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma

This Phase II trial is currently recruiting patients. Sorafenib is a "targeted drug" engineered to inhibit something called the RAF kinase within cancer cells. RAF in turn is part of the RAS oncogene pathway. RAS is a gene which drives cell division and is overexpressed in many cancers. In addition to targeting RAF kinase, sorafenib also inhibits the VEGF and PDGF receptors on blood vessel cells. Thus, sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. The purpose of this trial is to study how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma. Patients are stratified according to sarcoma histology (angiosarcoma vs. malignant peripheral nerve sheath tumor vs. leiomyosarcoma vs. high-grade undifferentiated pleomorphic sarcoma [i.e., malignant fibrous histiocytoma] vs. fibrosarcoma vs. all other types of sarcoma). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed at 4 weeks. A total of 222 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at centers in Illinois, Michigan, New York, Ohio, South Carolina, and Texas.

Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

This Phase II trial is currently recruiting patients. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor (see the sorafenib trial listed above) The purpose of this trial is to study how well sorafenib works in treating patients with advanced or recurrent uterine cancer, including recurrent uterine sarcoma. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. A total of 74 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Illinois, Indiana, Michigan, Missouri, Pennsylvania, Wisconsin, and Ontario Canada.

Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

This Phase II trial is currently recruiting patients. Trastuzumab is a monoclonal antibody; it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to study how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma. Patients receive trastuzumab (Herceptin^®) IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 weeks until disease progression and then every 6 months for up to 2 years from study entry. A total of 20-40 patients will be accrued for this study within 10-40 months. Patients 18 years of age and older are eligible. This trial is taking place at centers in Illinois, Indiana, Iowa, Kansas, Missouri, Montana, North Carolina, Ohio, South Carolina, Utah, Washington, and Wyoming.

Chemo Drug Sensitivity Microculture (MiCK) Assay for Apoptosis

This Phase II/III trial is currently recruiting patients. Identification of those patients who will or will not respond to a specific chemotherapy is important for making decisions regarding chemotherapy regimens as well as alternative management approaches. A laboratory test that could help to determine the sensitivity of an individual patient’s tumor cells to specific chemotherapeutic agents would be valuable in choosing the optimal chemotherapy regimen for that patient with an expectation of increasing the response rate to the therapy. Several types of in vitro assays that measure tumor cell survival following exposure to cytotoxic agents have been evaluated for their ability to predict chemotherapy outcomes. As a group, these assays are referred to as drug resistance assays. In a resistance assay, the surviving tumor cells can be detected directly by their exclusion or metabolism of specific dyes. Alternatively, since some of tumor cells are proliferating, their survival can be detected by measurement of DNA synthesis by radiolabeled precursor incorporation or demonstration of clonogenic potential by growth into colonies in semi-solid culture medium. In several clinical studies, these assays were useful in detecting drug resistance and in predicting a poor prognosis for cancer patients. However, these resistance assays cannot detect sensitivity of an individual patient’s tumor cells to a specific drug. Therefore, new methods determining drug-sensitivity of the tumor cells of an individual patient and, thus, capable of both predicting a positive treatment outcome and guiding chemotherapy, would be of significant value. Recently, Dr. Kravtsov has developed an automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells. Apoptosis is a distinct mode of cell death which occurs under physiological conditions and yet can be induced in malignant cells by chemical and physical factors including antitumor drugs. During the last decade, it has been recognized that chemotherapeutic agents exert their antitumor activity by triggering apoptosis in susc