Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

carmustine

polifeprosan 20 with carmustine implant

surgical procedure

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult brain stem glioma, adult mixed glioma, adult anaplastic astrocytoma, adult pilocytic astrocytoma, adult oligodendroglioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003467

First Posted

November 1, 1999

Last Updated

June 19, 2013

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00003467

Brief Title

Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

January 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor, adult brain stem glioma, adult mixed glioma, adult anaplastic astrocytoma, adult pilocytic astrocytoma, adult oligodendroglioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

carmustine

Intervention Type

Drug

Intervention Name(s)

polifeprosan 20 with carmustine implant

Intervention Type

Procedure

Intervention Name(s)

surgical procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry S. Friedman, MD

Organizational Affiliation

Duke University

Official's Role

Study Chair

Facility Information:

Facility Name

Duke Comprehensive Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Brain and Central Nervous System Tumors

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial