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Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer

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: NCT00007982
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 4, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Head and Neck Cancer Lymphoma Biological: filgrastim Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: thiotepa Procedure: adjuvant therapy Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • Determine the response rate in patients with central nervous system malignancies treated with intensive chemotherapy supported by autologous peripheral blood stem cell transplantation following surgical resection and/or radiotherapy.
  • Determine the disease-free survival and overall survival of this patient population treated with these regimens.
  • Determine the toxicity of this high-dose chemotherapy regimen in these patients.
  • Assess the quality of life of these patients following these treatment regimens.

OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or primary neuroectodermal tumor undergo initial surgical resection followed by conventional or stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and cisplatin prior to high-dose chemotherapy.

All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3, carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3. Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered concurrently with stem cell harvesting and transplantation.

Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose chemotherapy.

Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of life is assessed at follow-up.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
Study Start Date : April 1999
Actual Primary Completion Date : February 2005
Actual Study Completion Date : May 2008

Primary Outcome Measures :
  1. Response rate
  2. Disease-free suvival
  3. Overall survival
  4. Toxicity
  5. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant tumors

    • Anaplastic astrocytoma
    • Oligodendroglioma
    • Germ cell tumor
    • Medulloblastoma
    • Primary neuroectodermal tumor
    • Esthesioneuroblastoma
    • CNS lymphoma (primary or systemic disease)
  • Multifocal intracranial disease allowed
  • No extraneural metastases (except controlled systemic lymphoma)
  • Pretreatment considerations based on tumor type

    • Anaplastic astrocytoma:

      • Recurrent disease
      • Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2)
      • Chemotherapy not required at recurrence
    • Oligodendroglioma:

      • Disease response (at least minor) to conventional chemotherapy OR
      • Recurrent disease
    • Esthesioneuroblastoma:

      • Attempted complete surgical resection
      • Disease progression after radiotherapy
      • Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin
    • CNS lymphoma:

      • Disease refractory to methotrexate OR
      • Failure after initial treatment with methotrexate OR
      • Considered at high risk for disease relapse despite initial response
  • Radiographic or pathological confirmation of recurrent disease required
  • Not eligible for other high priority national or institutional clinical studies



  • 18 and over

Performance status:

  • ECOG or Zubrod 0-1

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Creatinine less than 1.5 times normal


  • LVEF at least 45%


  • DLCO at least 60% predicted OR
  • Approval of pulmonologist


  • Not pregnant or nursing
  • HIV negative


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent anticancer hormonal therapy
  • No concurrent steroids as antiemetics


  • See Disease Characteristics


  • See Disease Characteristics


  • No concurrent barbiturates or acetaminophen
  • Participation in other concurrent supportive care or gene therapy trials allowed

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): NCT00007982

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United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: Charles S. Hesdorffer, MD Herbert Irving Comprehensive Cancer Center

Layout table for additonal information Identifier: NCT00007982    
Other Study ID Numbers: CDR0000068360
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: July 2007
Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult medulloblastoma
adult oligodendroglioma
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
adult anaplastic astrocytoma
adult central nervous system germ cell tumor
primary central nervous system non-Hodgkin lymphoma
adult anaplastic oligodendroglioma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors