Testicular Germ Cell Tumor Clinical Trial
Official title:
Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the
number of immune cells found in bone marrow or peripheral blood and may help the immune
system recover from the side effects of chemotherapy. Giving combination chemotherapy
together with pegfilgrastim may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving combination
chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell
tumors.
OBJECTIVES:
Primary
- Determine the feasibility of accelerated treatment comprising bleomycin, etoposide,
cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.
- Determine the toxicity of this regimen (particularly with respect to renal, pulmonary,
and neurological function) in these patients.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a non-randomized, pilot study.
Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV
over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day
4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
;
Allocation: Non-Randomized, Primary Purpose: Treatment
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