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Completed

NCT Number: NCT00003467

Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carmustine

Drug

polifeprosan 20 with carmustine implant

Drug

Surgical Procedure

Procedure

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers

Important dates

Study start
1998
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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