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Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma

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: NCT00008008
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 work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: thiotepa 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, disease-free interval, and overall survival of patients with malignant glioma treated with high-dose thiotepa followed by autologous peripheral blood stem cell transplantation.
  • Determine the toxicity of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine whether this drug enters the cerebrospinal fluid of these patients.

OUTLINE: Following a course of induction chemotherapy with cyclophosphamide IV over 4 hours, patients receive filgrastim (G-CSF) daily until the completion of peripheral blood stem cell (PBSC) harvesting. PBSCs are collected over 3-5 days. Patients who do not mobilize sufficient cells undergo bone marrow harvest.

Patients receive high-dose thiotepa IV over 5 hours on day -2. PBSCs or bone marrow are reinfused on day 0. Patients receive sargramostim (GM-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover. Treatment repeats every 2-3 weeks for a total of 1-4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at every course, then monthly for 6 months, and then every 2 months thereafter.

Patients are followed monthly for 6 months and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 5-40 patients will be accrued for this study within 3 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CAMP 013:- Tandem Thiotepa Regimen For Selected Malignant Gliomas:1) Primary Or Recurrent Glioblastoma Multiforme (GBM); and 2) Recurrent Anaplastic Astrocytomas (AA), Oligodendrogliomas (O), Oligoastrocytomas (OA), Ependymomas And Primitive Neuroectodermal Tumors (PNET) That Have Either Progressed After Primary Therapy Or Are Refractory To Standard Chemotherapy
Study Start Date : September 1997
Actual Primary Completion Date : June 2005
Actual Study Completion Date : May 2008

Primary Outcome Measures :
  1. Response rate
  2. Disease-free interval
  3. Overall survival
  4. Toxicity

Secondary Outcome Measures :
  1. Pharmacokinetics
  2. Presence of high-dose thiotepa in the cerebrospinal fluid

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 malignant glioma

    • Primary or recurrent glioblastoma multiforme (including gliosarcoma) following surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or procarbazine, vincristine, and lomustine)
    • Recurrent or refractory anaplastic astrocytoma following any prior therapy (must be chemoresistant)
    • Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET) following any prior therapy
    • Recurrent or refractory oligodendroglioma or oligoastrocytoma following any prior therapy (must be chemoresistant)
  • Evaluable disease on gadolinium-enhanced MRI
  • Ineligible for other high priority national or institutional study (e.g., protocol CAMP-004)



  • Any age

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Creatinine less than 1.5 times normal


  • LVEF at least 45% by MUGA


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


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • 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 Surgery


  • See Disease Characteristics
  • For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic radiosurgery to reduce tumor bulk allowed


  • No concurrent acetaminophen during chemotherapy

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): NCT00008008

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United States, New Jersey
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
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: NCT00008008    
Other Study ID Numbers: CDR0000068362
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):
childhood infratentorial ependymoma
childhood supratentorial ependymoma
recurrent adult brain tumor
adult medulloblastoma
adult glioblastoma
adult oligodendroglioma
childhood high-grade cerebral astrocytoma
childhood oligodendroglioma
adult anaplastic astrocytoma
adult anaplastic ependymoma
adult mixed glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood ependymoma
adult giant cell glioblastoma
adult gliosarcoma
adult supratentorial primitive neuroectodermal tumor (PNET)
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
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