Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


Purpose:

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.


Criteria:

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


NCT ID:

NCT00070096


Primary Contact:

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


Backup Contact:

N/A


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: December 11, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.