Overview
Chemotherapy, Surgery, Radiation Therapy and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Primary CNS Germ Cell Tumors
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, surgery, radiation therapy, and bone marrow or peripheral stem cell transplantation in treating patients who have primary CNS germ cell tumors.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Hospital Los AngelesCollaborator:
National Cancer Institute (NCI)Treatments:
Carboplatin
Cyclophosphamide
Etoposide
Thiotepa
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed newly diagnosed primary CNS germ cell tumor OR
- Serum or cerebrospinal fluid (CSF) elevation of alpha-fetoprotein (AFP) or beta-human
chorionic gonadotropin (beta-HCG) greater than 50 ng/mL
- Low-risk disease:
- Histologically proven pure germinoma
- Localized, nonmetastatic disease
- Normal CSF
- Normal serum tumor markers
- Intermediate-risk disease:
- Histologically proven germinoma
- Beta-HCG-positive syncytiotrophoblastic giant cell component AND/OR
- CSF elevation of beta-HCG to less than 50 ng/mL
- High-risk disease:
- Histologically proven choriocarcinoma, endodermal sinus tumor, or embryonal
carcinoma
- Elevated serum and/or CSF AFP OR
- Elevated serum beta-HCG OR
- Elevated CSF beta-HCG greater than 50 ng/mL OR
- Disseminated disease by MRI and/or CSF cytology
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2.0 mg/dL
- Indirect hyperbilirubinemia due to Gilbert's syndrome is allowed
- AST and ALT less than 5 times upper limit of normal
Renal:
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- Cardiac function normal by echocardiogram
- No myocardial infarction or ischemia in patients over 30 years
- Fractional shortening greater than 30%
Other:
- No unacceptable morbidity of organ systems outside the CNS
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No concurrent corticosteroids administered solely for antiemesis during study
chemotherapy
Radiotherapy:
- No prior cranial radiotherapy
Surgery:
- Not specified