Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

Duke University

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: polifeprosan 20 with carmustine implant; Drug: carmustine; Procedure: surgical procedure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003467

NCI-G98-1470

DUMC-1568-98-10R1

CDR0000066503 (Other Identifier)

DUMC-97131

DUMC-000693-00-4

DUMC-1706-01-9R4

DUMC-1706-02-9R5

1706

DUMC-1706-00-9R3

DUMC-1509-97-10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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