Working… Menu

Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade 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: NCT00003467
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
National Cancer Institute (NCI)
Information provided by:
Duke University

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carmustine Drug: polifeprosan 20 with carmustine implant Procedure: surgical procedure Phase 2

Detailed Description:


  • Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.
  • Assess the toxicity of this therapy in these patients.

OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).

Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Primary Purpose: Treatment
Official Title: Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
Study Start Date : January 1998
Actual Study Completion Date : February 2004

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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


  • Histologically confirmed recurrent primary low grade glioma including:

    • Fibrillary astrocytoma
    • Oligodendroglioma
    • Mixed glioma
  • Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Hematocrit greater than 29%
  • Absolute neutrophil count greater than 1500/mm^3
  • Platelet count greater than 125,000/mm^3


  • SGOT less than 1.5 times upper limit of normal (ULN)
  • Bilirubin less than 1.5 times ULN


  • Creatinine less than 1.5 mg/dL
  • BUN less than 25 mg/dL


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


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy unless disease progression

Endocrine therapy:

  • Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)
  • No concurrent immunosuppressive agents


  • At least 4 weeks since prior radiotherapy unless disease progression


  • Not specified


  • No other concurrent medication that may interfere with study

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): NCT00003467

Layout table for location information
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Henry S. Friedman, MD Duke University

Layout table for additonal information
Responsible Party: Henry Friedman, MD, Duke UMC Identifier: NCT00003467     History of Changes
Other Study ID Numbers: 1706
CDR0000066503 ( Other Identifier: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: October 2009
Keywords provided by Duke University:
recurrent adult brain tumor
adult brain stem glioma
adult mixed glioma
adult anaplastic astrocytoma
adult pilocytic astrocytoma
adult oligodendroglioma
Additional relevant MeSH terms:
Layout table for MeSH terms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents