A Phase 2 interventional study of bleomycin sulfate and pegfilgrastim in Extragonadal Germ Cell Tumor, Teratoma and Testicular Germ Cell Tumor, sponsored by Cambridge University Hospitals NHS Foundation Trust. Completed at 7 sites in United Kingdom. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2013-08-07.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Phase 2, Interventional, and Treatment
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
Secondary
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Patients must fulfill all of the following criteria for 1 of the following diagnoses:
Nonseminoma germ cell tumor (intermediate risk)
Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:
Seminoma (intermediate prognosis)
Surveillance relapse
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Toxicity
Feasibility
Response rate
Progression-free survival
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Cambridge University Hospitals NHS Foundation Trust