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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025324
First received: October 11, 2001
Last updated: December 17, 2013
Last verified: December 2004
  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

Resource links provided by NLM:


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

Study Start Date: December 2000
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
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: December 17, 2013
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
Neoplasms by Site
Nervous System Diseases
Neoplasms by Histologic Type
Cyclophosphamide
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

ClinicalTrials.gov processed this record on September 16, 2014