Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI 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, NCT00003467

Objectives

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

Entry Criteria

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

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

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/mm³
• Platelet count greater than 125,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

Henry Friedman, MD, Protocol chair		Ph: 919-684-5301 Email: fried003@mc.duke.edu

Registry Information
Official Title		Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
Trial Start Date		1998-01-16
Registered in ClinicalTrials.gov		NCT00003467
Date Submitted to PDQ		1998-08-03
Information Last Verified		2003-05-06
NCI Grant/Contract Number		P30-CA14236