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Clinical Trials |
Clinical Trials that are No Longer Recruiting Patients or that have been Suspended, Completed, Withdrawn or Terminated
Study of IT-101 in the Treatment of Advanced Solid Tumors This Phase I trial is currently recruiting patients. IT-101 is a nanotechnology formulation being developed by Insert Therapeutics using its Cyclosert™ drug delivery technology platform. IT-101 is comprised of the Cyclosert™ delivery platform in combination with the anticancer compound camptothecin for systemic treatment of solid tumors, both primary and metastatic. Camptothecin is a natural compound found in the bark of the Chinese Camptotheca Acuminata tree. Camptothecin was discovered in the 1960s to possess potent anticancer properties against a broad spectrum of tumor cell lines. Its method of action inhibits the enzyme topoisomerase 1, which is key to the winding and unwinding process of DNA that is an essential step in cell division and replication. Interrupting this process prevents DNA replication and leads to cell death. However, camptothecin presents a formidable challenge for drug delivery technology, and was never successfully developed and commercialized in its native state due to several unfavorable characteristics. First, it is virtually insoluble in water, making any sort of systemic application difficult. Second, at human blood pH levels, it rapidly hydrolyzes from its active lactone form to its carboxylate form, which remains highly toxic, but lacks anticancer properties. Finally, in its carboxylate form camptothecin has a high binding affinity with human blood proteins in vivo which prevents the camptothecin from eventually equilibrating between its active and inactive forms. All of these properties dramatically reduced its efficacy and increased its toxicity in humans compared to results obtained in animal testing. IT-101 (using Cyclosert) is a conjugate of camptothecin (CPT) and a linear, cyclodextrin-based polymer (CDP). The components of CDP are beta-cyclodextrin and polyethylene-glycol (PEG), both of which are used in a variety of drug formulations. Camptothecin is covalently attached to CDP through a glycine linker which preserves CPT in its active form and increases its water solubility by greater than 1000 fold. Once injected into the blood circulation, camptothecin is slowly released from the polymer conjugate through hydrolysis of an ester linkage. In addition to improving solubility and stability, polymer-drug conjugation can enhance the accumulation of the drug in tumors by taking advantage of the enhanced permeability and retention (EPR) effect, a mechanism through which macromolecules extravasate out of the abnormally leaky vasculature of tumors. The instant trial will be an open-label, dose-escalation, study of IT-101 administered in patients with solid tumor malignancies. Patients who satisfy the inclusion/exclusion criteria will receive a weekly injection of IT-101 on Days 1-8-15 followed by a 1 week rest period. Patients may receive up to 6 cycles of IT-101. Patients will be monitored for a response using RECIST criteria every 2 months. Male and female patients 18 years of age and older with advanced solid tumors refractory to standard therapy or for which no standard therapy exists are eligible. The total expected enrollment is 36 patients. The trial is taking place at City of Hope National Medical Center, Duarte, California.
Study Evaluating AMG 386 in Adult Patients with Advanced Solid Tumors This Phase I trial has been completed. The purpose of this study was to test the safety, tolerability and pharmacokinetic profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors. Patients 18 years of age and older were eligible. This trial took place in California.
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors This Phase I trial is currently recruiting patients. Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors. The purpose of this trial is to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. This is a randomized study with a dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs. visceral metastases). Patients are randomized to 1 of 2 treatment arms as follows:
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses. Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to use the high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment. Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy. Patients are followed every 3 months. A total of 42 patients (21 per treatment arm; 12 in the cutaneous stratum and 30 in the visceral stratum) will be accrued for this study within 1-2 years. Patients 18 years of age and older are eligible. Herbert Irving Comprehensive Cancer Center at Columbia University, New York.
This Phase II trial is currently recruiting patients. Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells. This trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma. This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs. no). 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) on days 9-15 OR pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. A total of 12-43 patients will be accrued for this study within 12-28 months. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Connecticut, Delaware, Georgia, Illinois, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Virginia, and Wisconsin.
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 centers in California, Texas, and New Jersey.
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 Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania (for further details contact: Hanne Harbison 215-829-6712), with Dr. Sant P. Chawla, Santa Monica California (for further details contact: Vickie Chua 310-552-9999), and Karmanos Cancer Institute, Detroit, Michigan (for further details contact: Karen Forman 313-576-8096.
Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma This Phase I trial is no longer currently recruiting patients. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may be effective in treating soft tissue sarcoma. Thus, the purpose of this trial is to study the effectiveness of combining vaccine therapy with sargramostim in treating patients who have stage II, stage III, or stage IV soft tissue sarcoma, including synovial sarcoma. Patients receive NY-ESO-1 peptide vaccine intradermally once every 2 weeks for a total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) subcutaneously once daily beginning 2 days before every vaccination and continuing for 5 days. Treatment continues in the absence of disease progression or unacceptable toxicity. A total of 15 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York.
Long-Term Effects of Therapy in Patients Previously Treated for Childhood Soft Tissue Sarcoma This trial is no longer recruiting patients. Assessing the long-term effects of therapy in patients who have been treated for childhood soft tissue sarcoma may help improve the effectiveness of follow-up programs. The purpose of this trial is to determine the long-term effects of therapy in patients who were previously treated for childhood soft tissue sarcoma. Patients undergo evaluation of the following: cardiac dysfunction by echocardiogram, MUGA scan, and cardiac MRI with gadolinium texaphyrin contrast; gonadal dysfunction by physical examination, endocrine testing, and semen analysis; hormonal stress by serum hormone levels; musculoskeletal impairment by bone densitometry and musculoskeletal and functional testing by rehabilitation medicine specialists; transfusion-associated risks by hepatitis A, B, C, HIV, and HTLV-1 testing; and other major organ impairments. Quality of life and psychosocial effects (including post-traumatic stress syndrome) are also assessed. Approximately 50-100 patients will be accrued for this study. Patients 2 years of age and older are eligible. This trial is taking place at the Warren Grant Magnuson Clinical Center, Bethesda, Maryland.
Soblidotin in Treating Patients with Advanced or Metastatic Soft Tissue Sarcoma This Phase II trial has been completed. Soblidotin (also called TZT-1027) belongs to a family of drugs called tubulin inhibitors. Tubulin inhibitors attempt to stop tumor cells from dividing so the tumors stop growing or die. The purpose of this trial is to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma. This is an open-label, multicenter study. Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival. A total of 27 patients will be accrued for this study. Patients 15 years of age and older are eligible. This trial is taking place at centers in Alabama, Indiana, New York, Texas, and Puerto Rico.
Alanosine in Treating Patients With Cancer This trial is no longer recruiting patients. The purpose of this trial is to study the effectiveness of alanosine in treating patients who have soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or pancreatic cancer. This is a nonrandomized, open-label, multicenter study. Patients receive alanosine IV continuously on days 1-5. Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days. A total of 50-145 patients (10-29 per tumor type) will be accrued for this study. Patients 13 years of age and older are eligible. This trial is taking place at centers in Alabama, Arizona, California, Florida, Illinois, New York, Tennessee, and Texas.
This Phase I trial is no longer recruiting patients. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. The purpose of this trial is to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer, including soft tissue sarcoma, osteosarcoma, and Ewing’s sarcoma. At least 4 weeks prior to chemotherapy, patients undergo stem cell collection following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate. Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days, followed the next day by infusion of one fourth of the allotted stem cells, with the remaining allotment infused 2 days later. G-CSF is given for granulocyte support. Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5 days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined. Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the physician's discretion for at least 5 years. Three to six patients will be entered at each dose of paclitaxel studied. Patients between 18 and 55 years of age are eligible. This trial is taking place at City of Hope Comprehensive Cancer Center, Duarte, California.
This Phase I/II trial has been completed. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. The purpose of this trial is to study the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors, including soft tissue sarcomas. This is a dose escalation study of temozolomide. Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for 1-3 years, then annually thereafter. A total of 30 patients will be accrued for this study. Patients up to 18 years of age are eligible. This trial is taking place at the Duke Comprehensive Cancer Center, Durham, North Carolina.
A Study of ET743 in Subjects With Advanced Liposarcoma or Leiomyosarcoma This Phase II trial is no longer recruiting patients. The purpose of this study is to test the safety and effectiveness of the investigational chemotherapy agent ET-743 in subjects with advanced liposarcoma or leiomyosarcoma. ET-743 is a cytotoxic alkaloid derived from a marine organism which covalently binds to the minor groove of DNA and may inhibit DNA replication and transcription through other mechanisms. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the investigator conducting the study. Persons 18 years and older are eligible. Trial location information is not provided.
This Phase III study is no longer recruiting patients. The purpose of this trial is to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma. Patients are assigned to 1 of 2 groups, depending on histology and site of disease. In Group I patients receive: vincristine IV over 1 minute weekly for 8 weeks and dactinomycin IV over 1 minute once every 3 weeks for 4 doses. Treatment repeats every 12 weeks for 4 courses. Radiotherapy is administered to patients with clinical group II or III disease on weeks 3-8. In Group II patients receive: vincristine and dactinomycin as in group I. Patients also receive cyclophosphamide IV over 30-60 minutes and filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously once daily beginning 24 hours after completion of chemotherapy and continuing for 10 days or until blood counts recover. Radiotherapy is administered on weeks 3-8, 12-17, or 28-33, if clinically indicated as in group I. Patients are followed every 3-4 months for 3 years (4 years after diagnosis), every 6 months for 1 year, and then annually thereafter. A total of 254 patients for group I will be accrued for this study within 6 years. Approximately 12 patients per year will be accrued for group II. Patients under 50 years of age are eligible. This trial is taking place at centers in Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Puerto Rico, Canada, Australia, New Zealand, Netherlands, and Switzerland.
Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma This Phase III study is no longer recruiting patients. The purpose of this trial is to compare the effectiveness of two combination chemotherapy regimens in treating patients who have previously untreated rhabdomyosarcoma or sarcoma. Patients are stratified according to disease (embryonal histology, stage II or III, Clinical Group III vs. embryonal histology, Clinical Group IV, less than 10 years of age vs. alveolar or undifferentiated sarcoma histology, stage I, Clinical Group I vs. alveolar or undifferentiated sarcoma histology, stage II or III, Clinical Group II or III). Patients are randomized to 1 of 2 treatment arms:
Patients with Clinical Group II parameningeal tumors and Clinical Group III parameningeal tumors with base of skull erosion and/or cranial nerve palsy without evidence of intracranial extension receive radiotherapy on week 12 (day 84) or immediately thereafter. Patients with Clinical Group IV parameningeal tumors with distant metastases receive radiotherapy to the primary site on week 12 (day 84). Patients with distant metastases confined to one site may receive radiotherapy to the metastatic site concurrently with therapy to the primary site if it began within 2 weeks of the initiation of chemotherapy (day 0).
A total of 518 patients will be accrued for this study. Patients under 50 years of age are eligible. This trial is taking place at centers in Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Puerto Rico, Canada, Australia, New Zealand, Netherlands, and Switzerland.
This Phase II study is no longer recruiting patients. The purpose of this trial is to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma. The treatment outline for this study is as follows:
A total of 18-46 patients will be accrued for this study. Patients under 50 years of age are eligible. This trial is taking place at centers in Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Puerto Rico, Canada, Australia, New Zealand, Netherlands, and Switzerland.
This Phase II study is no longer recruiting patients. The purpose of this trial is to study the effectiveness of combination chemotherapy in treating children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors. Patients are stratified according to risk group (standard vs. high). The treatment outline for this study is as follows:
Standard-risk patients:
High-risk patients:
Patients achieving CR, unless metastatic disease is resected, undergo radiotherapy beginning on week 15. A total of 8-30 standard-risk patients and 15-75 high-risk patients will be accrued for this study. Patients 6 months to 17 years of age are eligible. This study is being conducted at centers in France, Ireland, and the United Kingdom.
Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma This Phase III study is no longer recruiting patients. The purpose of this study is to study the effectiveness of different regimens of combination chemotherapy with or without surgery and/or radiation therapy in treating patients with soft tissue sarcoma. This is a randomized study for patients with high-risk, nonmetastatic sarcoma. Patients are stratified according to disease type (rhabdomyosarcoma (RMS) vs. non-RMS disease) and parameningeal site of disease. Patients with RMS are further randomized by alveolar histology. Randomization occurs after the first course of chemotherapy. All patients, regardless of disease stage, are registered to this study and outcome is followed, although patients with metastatic RMS or non-RMS malignant mesenchymal tumors are referred for treatment on another study. Patients diagnosed more than 8 weeks prior to entry or who are unavailable for follow-up are not treated on study. Doses are modified for patients under 1 year of age or under 10 kg of body weight. All other patients are assigned therapy based on risk group. After surgery, patients with complete resection and with proven or possible chemosensitive histologies proceed to chemotherapy on a low-risk regimen. Patients with questionable completeness of resection proceed to chemotherapy for standard-risk or high-risk tumors, as appropriate. A total of 400 patients will be accrued for this study. Patients up to 17 years of age are eligible. The location of this study is at the Institute of Child Health, Bristol, England.
This Phase I study is no longer recruiting patients. The purpose of this study is to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors. Patients undergo surgery for diagnosis and maximal tumor resection. Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. A total of 83 patients will be accrued for this study. Patients 6 months to less than 3 years of age are eligible. This trial is taking place at centers in Arizona, California, Colorado, Connecticut, Delaware, the District of Columbia, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Canada, Australia, and New Zealand.
Irinotecan in Treating Children With Refractory Solid Tumors This Phase II study is no longer recruiting patients. The purpose of the study is to study the effectiveness of irinotecan in treating children who have refractory solid tumors, including Ewing’s sarcoma, rhabdomyosarcoma, and osteosarcoma. Patients are stratified according to type of solid tumor or brain tumor. Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. A total of 225 patients will be accrued for this study. Patients 1 to 21 years of age are eligible. This trial is taking place at centers in Arkansas, California, Connecticut, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Canada, Australia, New Zealand, Puerto Rico, and Switzerland.
This Phase I study is no longer recruiting patients. Filgrastim (granulocyte colony-stimulating factor) shortens the duration of chemotherapy-induced neutropenia and lowers the risk of infection. It is administered by daily subcutaneous injection after cytotoxic chemotherapy in children treated with dose-intensive chemotherapy, and has become a standard component of the treatment regimen. Filgrastim-SD/01 is a sustained duration form of Filgrastim. In phase I and phase II trials in adults, a single dose of Filgrastim-SD/01 appears to be equivalent to daily dosing of Filgrastim in enhancing neutrophil recovery and has a comparable adverse event profile. The purpose of this trial is to compare the tolerance, toxicity, and therapeutic effects of Filgrastim-SD/01 given as a single injection after chemotherapy to daily subcutaneous Filgrastim in patients with newly diagnosed sarcoma. The pharmacokinetics of Filgrastim-SD/01 will also be compared to the pharmacokinetics of Filgrastim. This trial will also be a platform for performing biological studies of these tumors and for detailed cardiac studies. High-risk patients who are treated on this front line trial and respond will also be candidates for a planned transplant protocol. A total of 34 patients (17 patients per treatment arm) will be recruited. Patients 25 years of age or less at the time of diagnosis are eligible. This trial is taking place at centers in Maryland, Ohio, and Washington.
Temozolomide and O6-Benzylguanine for Treating Childhood Cancers This Phase I study is no longer recruiting patients. This study will investigate the combined use of temozolomide (TMZ) and O6-benzylguanine (O6BG) for treating cancer. TMZ is an anti-cancer drug approved to treat certain brain tumors in adults. TMZ loses its effectiveness over time because a protein called AGT makes the tumor resistant to the drug. O6BG inactivates AGT and, therefore, may prolong TMZ's effectiveness. Children and young adults under age 21 with various types of cancer, including sarcomas, for whom standard treatment was not successful may be eligible for this study. Participants will receive TMZ capsules by mouth and an intravenous infusion of O6BG 5 days in a row every month for up to 12 months. Blood will be drawn on days 3 and 5 of the first course of treatment to measure AGT levels. Also on day 5 of the first treatment course, 16 blood samples (1 teaspoon each) will be taken over a 48-hour period to study how the two drugs work in the body. If possible, a heparin lock will be placed in the vein to avoid having multiple needle sticks. A tissue biopsy (removal of a small piece of tumor) may be taken if the tumor is close to the skin and not near a vital organ. The sample will be used to evaluate the effect of O6BG on AGT levels. A total of 48 patients will be recruited. This trial is taking place at the Warren Grant Magnuson Clinical Center, Bethesda, Maryland.
Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors This Phase I trial has been completed. The purpose of this trial is to study the effectiveness of combining erlotinib with temozolomide in treating young patients who have recurrent or refractory solid tumors, including osteogenic sarcoma, rhabdomyosarcoma, and soft tissue sarcoma (excluding Ewing’s sarcoma). This is a multicenter, dose-escalation study of erlotinib. Patients are stratified according to pretreatment (heavily pretreated vs. less heavily pretreated). Patients receive oral erlotinib once daily on days 1-28. Beginning with course 2, patients also receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib during course 1 only 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 9-24 patients will be accrued for this study. Patients 21 years of age and under are eligible. This trial is taking place at centers in California, the District of Columbia, Indiana, Maryland, Massachusetts, Minnesota, Mississippi, New York, Ohio, Oregon, Pennsylvania, Texas, Washington, and Canada.
This Phase I trial is no longer recruiting patients. The purpose of this trial is to study the effectiveness of combining liposomaldoxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma. This is a dose-escalation study of ifosfamide. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4 hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 3-24 patients will be accrued for this study. Patients 18 to 70 years of age are eligible. This study is being conducted at centers in Denmark and Germany.
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma This Phase II trial is no longer recruiting patients. The purpose of this trial is to |
