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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)

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