Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.

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

Details

• Lead Sponsor: Children's Cancer and Leukaemia Group
• Treatments: Bleomycin; Carboplatin; Etoposide; Ifosfamide; Vinblastine

Criteria

DISEASE CHARACTERISTICS:

• Histologically* proven extracranial malignant germ cell tumor (GCT), including mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human chorionic gonadotropin (HCG) levels

• Newly diagnosed disease

• Patients with relapsed or progressive extracranial malignant GCT allowed if previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy

• Patients relapsing following JEB are eligible for the study relapse strategy NOTE: *Patients with unequivocally raised AFP/HCG whose risk of biopsy is felt to be high can be diagnosed by clinical grounds, imaging, and markers

• No intracranial GCTs

PATIENT CHARACTERISTICS:

• Neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• ALT ≤ 3 times ULN

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy other than JEB