Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Treatments: Bleomycin; Etoposide

Criteria

DISEASE CHARACTERISTICS:

• Patients must fulfill all of the following criteria for 1 of the following diagnoses:

• Nonseminoma germ cell tumor (intermediate risk)

• Testis or retroperitoneal primary

• Abnormal markers (alpha fetoprotein [AFP] > 1,000 and < 10,000 ng/mL, human chorionic gonadotropin [HCG] > 5,000 and < 50,000 IU/L, lactate dehydrogenase [LDH] > 1.5 times and < 10 times upper limit of normal [ULN])

• No liver, bone, brain, or other nonpulmonary visceral metastasis

• Histologic confirmation is not required if AFP or HCG are grossly elevated

• Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:

• Mediastinal primary

• Nonpulmonary visceral metastases

• Poor markers (AFP > 10,000 ng/mL, HCG > 50,000 IU/L, LDH > 10 times ULN)

• Histologic confirmation not required if AFP or HCG are grossly elevated

• Seminoma (intermediate prognosis)

• Histological confirmation is required

• Any primary site

• Nonpulmonary visceral metastases must be present

• Normal AFP

• Any HCG

• Any LDH

• Surveillance relapse

• Must fulfill appropriate criteria above according to initial histology

PATIENT CHARACTERISTICS:

• Neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³

• Must have adequate renal function (creatinine clearance ≥ 60 mL/min)

• No prior malignancy except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy