Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

NCT ID: NCT00003467

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-01-31
• Study Completion Date: 2004-02-29

Brief Summary

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.

Detailed 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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carmustine

Intervention Type: DRUG

polifeprosan 20 with carmustine implant

Intervention Type: DRUG

surgical procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Duke UMC

Principal Investigators

Henry S. Friedman, MD

Role: STUDY_CHAIR

Duke University

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-1706-02-9R5

Identifier Type: -

Identifier Source: secondary_id

DUMC-1706-01-9R4

Identifier Type: -

Identifier Source: secondary_id

DUMC-000693-00-4

Identifier Type: -

Identifier Source: secondary_id

DUMC-1509-97-10

Identifier Type: -

Identifier Source: secondary_id

DUMC-1568-98-10R1

Identifier Type: -

Identifier Source: secondary_id

DUMC-1706-00-9R3

Identifier Type: -

Identifier Source: secondary_id

DUMC-97131

Identifier Type: -

Identifier Source: secondary_id

NCI-G98-1470

Identifier Type: -

Identifier Source: secondary_id

CDR0000066503

Identifier Type: OTHER

Identifier Source: secondary_id

1706

Identifier Type: -

Identifier Source: org_study_id