Expired Study
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New York, New York 10021


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.

Study summary:

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.


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



Primary Contact:

Principal Investigator
Gnanamba V. Kondagunta, MD
Memorial Sloan-Kettering Cancer Center

Backup Contact:


Location Contact:

New York, New York 10021
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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