Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003467
• Other study ID #: 1706
• Secondary ID: DUMC-1706-02-9R5
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 19, 2013
• Start date: January 1998
• Est. completion date: February 2004

Study information

• Verified date: October 2009
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• carmustine

• polifeprosan 20 with carmustine implant

Procedure:
• surgical procedure

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,