Chemotherapy, Surgery, Radiation Therapy and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Primary CNS Germ Cell Tumors
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Correlative Studies In Primary Central Nervous System Germ Cell Tumors: The Third International CNS Germ Cell Tumor Study Group Protocol |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| United States, Virginia | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Study Chair: | Jonathan L. Finlay, MB, ChB | Children's Hospital Los Angeles |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00025324 History of Changes |
| Other Study ID Numbers: | CDR0000068950, CHLA-NYU-0007H, NCI-G01-2019 |
| Study First Received: | October 11, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
childhood central nervous system germ cell tumor adult central nervous system germ cell tumor |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Site Neoplasms Nervous System Diseases Neoplasms by Histologic Type Cyclophosphamide Thiotepa Etoposide Carboplatin Lenograstim Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on June 18, 2013