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	Treatment or Intervention	Phase
recurrent adult brain tumor adult brain stem glioma adult noninfiltrating astrocytoma adult well-differentiated mildly and moderately anaplastic astrocytoma adult well-differentiated oligodendroglioma Mixed Gliomas	Drug: carmustine  Drug: polifeprosan 20 with carmustine implant  Procedure: chemotherapy  Procedure: surgery	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Study chairs or principal investigators

Henry S. Friedman, MD,  Study Chair,  Duke Comprehensive Cancer Center   

Study ID Numbers:  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
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003467
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08