Clinical trial · Interventional
Chemotherapy, Surgery, Radiation Therapy and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Primary CNS Germ Cell Tumors
Clinical Correlative Studies In Primary Central Nervous System Germ Cell Tumors: The Third International CNS Germ Cell Tumor Study Group Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available