Clinical Trials

Clinical Trials Not Yet Accepting Patients

A Placebo-Controlled Study of AZD0530 in Patients With Recurrent Osteosarcoma Localized to the Lung

This Phase II trial is not yet open for patient recruitment.  The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking AZD0530 compared to patients taking placebo (a sugar pill). After complete surgical removal of their cancer, patients will be randomly assigned to receive either AZD0530 or placebo (a sugar pill) throughout the study. Patients will take AZD0530 (or placebo) once daily by mouth for a total of 364 days. The duration of treatment is divided into 13 cycles, 28 days each cycle with no breaks in between. Patients will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. To monitor for recurrence of tumor, patients will undergo thoracic CT scans at 3-4 weeks, 6-8 weeks, at 3 months, at 6 months, at 9 months, at 12 months, then every 6 months up to 2 years, and then every year up to 5 years after starting treatment. An electrocardiogram (ECG) will be taken at 3 months, and a bone scan will be performed at 12 months. Blood and tumor samples for research purposes will be collected at the time the tumor is removed. After completing all 13 cycles, patients will be followed for approximately every 3 months until 2 years from starting treatment, then approximately every 6 months until 4 years from starting treatment, and once at year 5. The estimate enrollment is 88 patients.  Patients 15 to 74 years of age are eligible. This trial is taking place at the National Cancer Institute, Bethesda, Maryland.

Monoclonal Antibody R1507 in Treating Young Patients With Recurrent or Refractory Advanced Solid Tumors

This Phase I trial is net yet open for recruiting patients. Monoclonal antibodies, such as R1507, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. This phase I trial is studying the side effects and best dose of monoclonal antibody R1507 in treating young patients with recurrent or refractory advanced solid tumors. Patients receive anti-IGF-1 receptor human monoclonal antibody R1507 (R1507) IV over 60-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Archival tumor tissue from original biopsy or surgical pathology specimens is obtained at baseline for pharmacodynamic studies. Tissue samples are examined by immunohistochemistry for biomarker proteins related to R1507 activity in insulin-like growth factor-1 receptor (IGF-1R)-signaling pathways. Blood specimens are obtained at baseline and periodically during study for pharmacokinetic and pharmacodynamic studies. Blood specimens are examined for IGF-1R-signaling biomarker proteins and changes in IGF-1R -signaling patterns after treatment with R1507. Blood specimens are also examined for human-anti-human antibodies and lymphocyte subsets. Positron emission tomography scans using the tracer, fluorine-18 (F-18) fluorodeoxyglucose (FDG), are performed at baseline and after the week 2 dose to assess the early effects of R1507 on metabolic activity in tumor tissue. After completion of study therapy, patients are followed at day 30. The total enrollment is 32 patients. Patients 2 to 17 years of age are eligible. The locations of this trial have not yet been identified.

Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors 

This Phase I trial is not yet open for patient recruitment. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with chemotherapy may kill more tumor cells. This trial is studying the side effects and best dose of temsirolimus, carboplatin, and paclitaxel in treating patients with advanced solid tumors. This is a multicenter, open-label, dose-escalation study. The treatment outline is as follows.

	Part A: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1 and temsirolimus IV over 30 minutes on days 8 and 15.
	Part B: Patients receive paclitaxel and carboplatin as in part A. They also receive temsirolimus IV over 30 minutes on days 8 and 15 in course 1 and on days 1, 8, and 15 in course 2 and all subsequent courses.

In each part, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients in part B also undergo blood collection periodically for pharmacokinetic studies. In each part, cohorts of 3-6 patients receive escalating doses of temsirolimus, carboplatin, and paclitaxel 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. The recommended phase II dose (RPTD) is the dose that is one dose level below the MTD. Once the RPTD is determined in part A, patients begin entry in part B. Up to 10 patients with endometrial or ovarian cancer are treated at the RPTD determined in part B of the study. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter. A total of 30 patients will be accrued for this study. Patients 18 years of age and older are eligible. The location of this trial has not yet been identified.

Treatment With MK6592 and an Anti-Cancer Drug in Patients With Advanced Solid Tumors 

This Phase I trial is not yet open for patient recruitment. The purpose of this trial is to evaluate the safety and tolerability of MK6592 in combination with an anti-cancer drug in adult patients with advanced solid tumors. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants). Further study details as provided by Merck. Patients with advanced solid tumors (metastatic or local) unresponsive to standard therapy, progressed on standard therapy, or for whom no standard therapy exists are eligible. There is no limit to the number of prior treatment regimens. Patients 18 years of age and older are eligible. The location of this trial is not identified. For further information call: 1-888-577-8839.

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

This Phase III trial is not yet open for patient recruitment. Drugs used in chemotherapy, such as vincristine, dactinomycin, cyclophosphamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma. The purpose of this trial is to study two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. This is a prospective, historic control, randomized, multicenter study. Patients are stratified according to histology, disease stage, and clinical group (group III, stage 2 or 3 embryonal rhabdomyosarcoma [RMS] vs. group I, stage 1 alveolar RMS vs. group II or III, stage 2 or 3 alveolar RMS). Patients are randomized to 1 of 2 treatment arms within 42 days of initial surgery or biopsy:

Arm I (VAC): Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40.

Arm II (VAC/VI): Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 5, 7, 8, 16, 17, 19, 20, 25, 26, 31, 32, 37, and 38.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients* in both arms also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4 (except patients with alveolar RMS rendered group I by amputation OR patients needing week 1 emergency radiotherapy for symptomatic spinal cord compression). NOTE: *Individualized local control plan that deviates from protocol-mandated radiotherapy allowed for patients ≤ 24 months of age. After completion of study treatment, patients are followed periodically for ≥ 10 years. A total of 486 patients will be accrued for this study. Patients up to 50 years of age are eligible. The location of this trial is not yet identified.

Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

This Phase IIIb trial is not yet open for patient recruitment. This is a Phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or Imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for one year. The primary outcome of the trial is to evaluate the duration of progression free survival (PFS) on sunitanib or imitanib. PFS is defined as the time from date of first treatment dose to progression of the gastrointestinal stromal tumor or death for any reason, whichever comes first.
The secondary outcomes are: Objective response (OR); Time-to tumor response (TTR); Duration of response (DR); Time-to-treatment failure (TTF); Overall survival time; Pain relief/ Pain progression; Patient-reported outcomes safety and tolerability of sunitinib administered in a continuous treatment regimen compared to imatinib. The total expected enrollment is 212 patients.  The study will start in November 2006. Patients 18 years of age and older are eligible. To obtain contact information for a study center near you, click here.

Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

This Phase II trial is not yet open for patient recruitment. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The purpose of this trial is to study how well trabectedin works in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus. This is a nonrandomized, multicenter study. Patients receive trabectedin IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete response may receive at least 2 additional courses. After completion of study treatment, patients are followed every 3 months. A total of 43 patients will be accrued for this study. Patients 18 years of age and older are eligible. The locations of this trial are not yet identified.

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

This Phase III trial is not yet open for patient recruitment. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known which regimen is more effective in treating soft tissue sarcoma. The purpose of this trial is to study observation to see how well it works compared with radiation therapy, combination chemotherapy, and/or surgery in treating patients with soft tissue sarcoma. This is a multicenter study. Patients are divided into 3 risk groups according to presence of metastatic disease (yes vs. no), status of prior surgery (resected vs. unresected), grade of tumor (low vs. high), and size of primary tumor (≤ 5 cm vs. > 5 cm). Patients are assigned to different treatment regimens based on disease extent (nonmetastatic vs. metastatic), tumor size (≤ 5 cm vs. > 5 cm), extent of resection of primary tumor (resected vs. unresected), extent of resection of metastases (complete or microscopic residual vs. gross residual), microscopic tumor margins (negative vs. positive), and tumor grade (low vs. high).

	Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to regimen A. Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to regimen B.
	Regimen A (observation only): Patients undergo observation only.
	Regimen B (adjuvant radiotherapy): Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.
	Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to regimen C. Patients with unresected tumor are assigned to regimen D.
	Regimen C (adjuvant chemoradiotherapy): Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, 10, 13, and 16 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1, 4, 13, 16, and 19. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.
	Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, and 10 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1 and 4. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy*. Patients undergo surgical resection in week 13.

NOTE: *Patients with primary hepatic tumors do not receive radiotherapy in week 4.

Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 16 and 19 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 16, 19*, and 22. Beginning in week 16, patients achieving gross total resection with positive microscopic margins undergo a total of 6 fractions of adjuvant radiotherapy. Patients achieving less than total gross resection undergo a total of 11 fractions of adjuvant radiotherapy. Patients achieving total gross resection with negative microscopic margins do not receive adjuvant radiotherapy.

NOTE: *Patients who receive adjuvant radiotherapy in week 16 receive doxorubicin hydrochloride in week 25 instead of week 19.

Group 3 (high risk [metastatic, resected, incompletely resected, or unresected disease]): Patients with high-grade, all-sites resected tumor with either negative or positive microscopic margins are assigned to receive treatment as in group 1 regimen A. Patients with low-grade, grossly resected primary tumor, and incomplete resection of metastatic sites are assigned to receive treatment as in group 2 regimen C. Patients with unresected, high-grade tumor are assigned to receive treatment as in group 2 regimen D.

In all groups, treatment continues in the absence of disease progression. After completing study treatment, patients are followed periodically for at least 5 years. A total of 865 patients will be accrued for this study. Patients up to 29 years of age are eligible. The locations of this trial are not yet identified.

AZD2171 in Treating Young Patients With Refractory or Recurrent Solid Tumors or Acute Myeloid Leukemia

This Phase I trial is not yet open for patient recruitment. AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. The purpose of this trial is to study the side effects and best dose of AZD2171 in treating young patients with refractory or recurrent solid tumors or acute myeloid leukemia. This is an open-label, dose-escalation study. Patients are stratified according to diagnosis (solid tumor vs. acute myeloid leukemia

Stratum 1 (solid tumor): Patients receive oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of AZD2171 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 during the first course of therapy. Up to 9 patients, preferably at least 3 patients < 12 years of age and at least 3 patients ≥ 12 years of age, are treated at the MTD.

Stratum 2 (acute myeloid leukemia): Patients receive AZD2171 as in stratum 1 at one dose level below the solid tumor MTD OR at the solid tumor MTD.

Patients undergo blood collection periodically during study for pharmacologic and pharmacodynamic correlative studies. A total of 33 patients will be accrued for this study. Patients between 2 and 18 years of age are eligible. The location of this trial is not yet identified.

Combination Chemotherapy With or Without Topotecan in Treating Patients With Newly Diagnosed Localized Ewing's

This Phase III trial is not yet open for patient recruitment. Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide, and topotecan, 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. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating Ewing's sarcoma.  The purpose of this trial is to study combination chemotherapy and topotecan to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed localized Ewing's sarcoma. This is a randomized, multicenter study. Patients are stratified according to age (≤ 17 vs. ≥ 18 years of age) and primary tumor site (pelvic vs. nonpelvic [including extra-osseous Ewing's sarcoma]). Patients are randomized to 1 of 2 treatment arms:

Arm I: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3, 7-9, and 13-15; doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 1, 7, and 13; cyclophosphamide IV over 1 hour on day 1 in weeks 1, 7, and 13; and ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4, 10, and 16. Patients undergo local therapy comprising surgical resection in approximately week 18 and/or radiotherapy beginning in approximately week 19. Patients then receive vincristine as above in weeks 19-21, 28-30, 34-36, 40-42, and 46-51; dexrazoxane hydrochloride IV over 15 minutes on days 1 and 2 and doxorubicin hydrochloride as above in weeks 19 and 28; cyclophosphamide as above in weeks 19, 28, 34, 40, 46, and 49; and ifosfamide and etoposide as above in weeks 22, 25, 31, 37, and 43.

Arm II: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3, 7-9, and 13-16; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 13; cyclophosphamide IV over 30 minutes on days 1-5 in weeks 1 and 13 and IV over 1 hour on day 1 in weeks 7 and 16; ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4 and 10; and doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 7 and 16. Patients undergo local therapy comprising surgical resection in approximately week 18 and/or radiotherapy beginning in approximately week 19. Patients then receive vincristine as above in weeks 19-21, 28-33, 37-42, and 46-48; topotecan hydrochloride as above in weeks 19, 31, and 40; cyclophosphamide IV over 30 minutes in weeks 19, 31, and 40 and IV over 1 hour in weeks 28, 37, and 46; ifosfamide and etoposide as above in weeks 22, 25, 34, 43, and 49; dexrazoxane hydrochloride IV over 15 minutes on days 1 and 2 in weeks 37 and 46; and doxorubicin hydrochloride as above in weeks 28, 37, and 46.

After completion of study treatment, patients are followed periodically for 5 years. A total of 528 patients will be accrued for this study. Patient up to 50 years of age are eligible. The location of this trial is not yet identified.

EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children

This Phase IV trial is not yet open for patient recruitment. The purpose of the study is to achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase. Patients 6 months to 21years of age with non-metastatic rhabdomyosarcoma are eligible. Further study details as provided by the Sheba Medical Center – click here.

Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

This Phase II trial is not yet open for patient recruitment. This phase II trial is studying how well ecteinascidin 743 works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma family of tumors vs. rhabdomyosarcoma vs. nonrhabdomyosarcomatous soft tissue sarcoma). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days. A total of 30-60 patients (10-20 per stratum) will be accrued for this study within 2 years. Patients up to 21 years of age are eligible. The location of this trial is not specified.

Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

This Phase III trial is not yet open for patient recruitment. This trial is for patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or Imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for one year. The total expected enrollment is 212 patients and the study is expected to start in November 2006. Patients 18 years of age and older are eligible. To obtain contact information for a study center near you, click here.

Phase I and II Trial With TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients 

This Phase I/II trial is not yet open for patient recruitment. TLC D-99 is a liposomal formulation of the anti-neoplastic drug doxorubicin with an improved therapeutic index compared with conventional doxorubicin. The purpose of this study is to determine the maximum tolerated dose of TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response. Soft tissue sarcoma patients 18 years of age and older are eligible. The treatment outline is not set forth. This trial is taking place at the Istituto Clinico Humanitas, Rozzano, Milan, Italy. For further information contact: Armando Santoro, MD, Principal Investigator.

Copyright © 2006, 2007 Liddy Shriver Sarcoma Initiative