Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; National Cancer Institute (NCI); Southwest Oncology Group
• Treatments: Bleomycin; Carboplatin; Cyclophosphamide; Etoposide

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven poor-risk, nonseminoma germ cell tumor

• Must meet 1 of the following 3 conditions:

• Testis or retroperitoneal primary site without visceral metastasis but with any of the following tumor marker values:

• Lactic dehydrogenase (LDH) greater than 10 times upper limit of normal (ULN)

• Human chorionic gonadotropin (hCG) greater than 50,000 IU/L

• Alpha-fetoprotein (AFP) greater than 10,000 ng/mL

• Testis or retroperitoneal primary site with 1 or more nonpulmonary visceral metastases (regardless of tumor marker values), including the following:

• Bone

• Brain

• Liver

• Other nonpulmonary viscera (e.g., skin, spleen)

• Mediastinal primary site, regardless of presence/absence of visceral metastasis or tumor marker values OR

• Histologically proven intermediate-risk, nonseminoma germ cell tumor

• Testis or retroperitoneal primary site with no visceral metastasis (except lung), and with any of the following tumor marker values:

• LDH 3-10 times ULN

• hCG 5,000-50,000 IU/L

• AFP 1,000-10,000 ng/mL OR

• Histologically proven intermediate-risk, seminoma germ cell tumor with 1 or more nonpulmonary visceral metastases (regardless of tumor marker values or primary site), including the following:

• Bone

• Brain

• Liver

• Other nonpulmonary visceral metastasis (e.g., skin, spleen)

• Histologic confirmation may be delayed, at the discretion of the protocol chairman, until after initiation of study therapy for patients with a testicular mass and elevated AFP or hCG if medical circumstances warrant immediate treatment

• Measurable or evaluable disease

• Concurrent registration on protocol MSKCC-89076 (SWOG-9345) for tumor biology studies required

PATIENT CHARACTERISTICS:

Age:

• 12 and over

Sex:

• Male

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• See Disease Characteristics

Renal:

• Creatinine no greater than ULN* OR

• Creatinine clearance greater than 50 mL/min* NOTE: * Abnormal levels due to ureteral obstruction by tumor allowed at the discretion of the protocol chairman

Other:

• HIV negative

• No other concurrent malignancy except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 30 days since prior radiotherapy except for brain metastases or documented disease progression

• Recovered from the toxic effects of any prior radiotherapy

Surgery:

• Recovered from the effects of any recent surgery