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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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Children's Hospital Los Angeles
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025324
  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
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: filgrastim
Drug: thiotepa
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer   

Drug Information available for:   Cyclophosphamide    Carboplatin    Filgrastim    Etoposide    Thiotepa    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Clinical Correlative Studies In Primary Central Nervous System Germ Cell Tumors: The Third International CNS Germ Cell Tumor Study Group Protocol

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 2000

Show detailed description  Show Detailed Description

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025324

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

Sponsors and Collaborators
Children's Hospital Los Angeles
National Cancer Institute (NCI)

Investigators
Study Chair:     Jonathan L. Finlay, MB, ChB     Children's Hospital Los Angeles    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068950, CHLA-NYU-0007H, NCI-G01-2019
First Received:   October 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00025324
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  

Study placed in the following topic categories:
Neoplasms, Germ Cell and Embryonal
Carboplatin
Cyclophosphamide
Central Nervous System Neoplasms
Etoposide phosphate
Etoposide
Nervous System Neoplasms
Thiotepa

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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