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BMS-247550 in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors



BMS-247550 in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors

For Condition: ovarian germ cell tumor,extragonadal germ cell tumor,adult brain tumor,Testicular Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as BMS-247550 use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have germ cell tumors that are refractory to cisplatin.
Details: OBJECTIVES: - Determine the efficacy of BMS-247550 in patients with advanced cisplatin-refractory germ cell tumors. - Determine the safety of this drug in these patients. OUTLINE: Patients receive BMS-247550 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per group) will be accrued for this study within 2-3 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting criteria for 1 of the following: - Measurable metastatic disease by radiography - If eligibility is defined by measurable disease only, there must be at least 1 site that has not been previously irradiated - Alpha-fetoprotein greater than 15 ng/mL and/or ß-human chorionic gonadotropin greater than 2.2 mIU/L - Previously treated disease meeting criteria for 1 of the following groups: - Primary mediastinal nonseminomatous GCT AND failed 1 prior cisplatin-based regimen - Primary refractory GCT after 1 cisplatin-based regimen, defined as minimal or no response to initial therapy - Poor candidate for conventional or high-dose salvage therapy due to comorbid medical conditions AND failed 1 prior cisplatin-based regimen - Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed) - Deemed to be cisplatin-refractory after more than 1 prior regimen AND does not want to have potentially curative high-dose therapy PATIENT CHARACTERISTICS: Age - 16 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than 1.5 times normal - SGOT no greater than 2 times upper limit of normal Renal - Creatinine no greater than 2.2 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - No other concurrent cytotoxic chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No concurrent radiotherapy Surgery - Not specified Other - No other concurrent experimental or commercial anticancer medications or therapies
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertMotzer,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Dean  Bajorin 646-422-4333


Additional Information:
Study ID Numbers:  CDR0000329992;  MSKCC-03041,NCI-6022
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070096

Other Ovarian Germ Cell Tumor Studies:
1. Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma

2. Imatinib Mesylate in Treating Patients With Gliomas

3. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors

4. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma

5. Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

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