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