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Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
This study has been completed.
Study NCT00003467   Information provided by Duke University
First Received: November 1, 1999   Last Updated: October 12, 2009   History of Changes

November 1, 1999
October 12, 2009
January 1998
 
 
 
Complete list of historical versions of study NCT00003467 on ClinicalTrials.gov Archive Site
 
 
 
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers

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.

OBJECTIVES:

  • 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.

Phase II
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: carmustine
  • Drug: polifeprosan 20 with carmustine implant
  • Procedure: surgical procedure
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
68
February 2004
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent primary low grade glioma including:

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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

  • At least 4 weeks since prior radiotherapy unless disease progression

Surgery:

  • Not specified

Other:

  • No other concurrent medication that may interfere with study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003467
Henry Friedman, MD, Duke UMC
CDR0000066503, DUMC-1706-02-9R5, DUMC-1706-01-9R4, DUMC-000693-00-4, DUMC-1509-97-10, DUMC-1568-98-10R1, DUMC-1706-00-9R3, DUMC-97131, NCI-G98-1470
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke University
Duke University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP