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Chemotherapy, Surgery, Radiation Therapy and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Primary CNS Germ Cell Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025324
Recruitment Status : Unknown
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Masking: None (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
Study Start Date : December 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • 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


  • Creatinine clearance greater than 60 mL/min


  • Cardiac function normal by echocardiogram
  • No myocardial infarction or ischemia in patients over 30 years
  • Fractional shortening greater than 30%


  • No unacceptable morbidity of organ systems outside the CNS
  • Not pregnant
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids administered solely for antiemesis during study chemotherapy


  • No prior cranial radiotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025324

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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
Sponsors and Collaborators
Children's Hospital Los Angeles
National Cancer Institute (NCI)
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Study Chair: Jonathan L. Finlay, MB, ChB Children's Hospital Los Angeles
Layout table for additonal information Identifier: NCT00025324    
Other Study ID Numbers: CDR0000068950
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2004
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:
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Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors