Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin.

Detailed Description
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OBJECTIVES: Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors. Determine the safety of this drug in these patients. OUTLINE: Patients receive ixabepilone 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 10-29 patients will be accrued for this study within 1.3-4 years.

Official Title
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A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL

Conditions
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Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

Intervention / Treatment
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* Drug: ixabepilone


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria: Measurable metastatic disease by one of the following methods: 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 progressive disease meeting 1 of the following criteria: Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed) Deemed to be cisplatin-refractory after prior cisplatin-based regimen AND does not want to have potentially curative high-dose therapy (mediastinal or primary refractory GCT) Prior treatment with 1 cisplatin-based regimen (primary mediastinal nonseminomatous GCT) 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ixabepilone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| Safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, adult central nervous system germ cell tumor, recurrent malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, testicular seminoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, recurrent extragonadal germ cell tumor, testicular immature teratoma, testicular mature teratoma