Carmustine Plus O(6)-Benzylguanine in Treating Patients With Recurrent or Progressive Gliomas of the Brain

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

O6-benzylguanine

carmustine

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven recurrent, persistent, or progressive glioblastoma multiforme or anaplastic astrocytoma diagnosed by biopsy/resection Evaluable residual disease by MRI or CT scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin within normal limits Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min BUN no greater than 25 mg/dL Pulmonary: DLCO greater than 80% predicted Other: Not pregnant or nursing Fertile patients must use effective contraceptive method during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosourea, procarbazine, or mitomycin) and recovered Endocrine therapy: Concurrent corticosteroid therapy must be stable for at least 1 week prior to study, if clinically possible Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified

Sites / Locations

Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003348

First Posted

November 1, 1999

Last Updated

February 15, 2013

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00003348

Brief Title

Carmustine Plus O(6)-Benzylguanine in Treating Patients With Recurrent or Progressive Gliomas of the Brain

Official Title

Phase I Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent, Persistent or Progressive Cerebral Anaplastic Gliomas

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

May 1998 (undefined)

Primary Completion Date

August 2000 (Actual)

Study Completion Date

August 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of carmustine plus O(6)-benzylguanine in treating patients who have recurrent or progressive gliomas of the brain.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of carmustine when administered following O6-benzylguanine in patients with recurrent, persistent, or progressive cerebral anaplastic gliomas. II. Characterize the toxic effects associated with this treatment regimen in these patients. III. Observe patients for clinical antitumor response when treated with this regimen. OUTLINE: Patients are stratified according to prior nitrosourea administration (yes or no). (Prior nitrosoureas stratum closed) An initial cohort of 3 patients per stratum is treated with intravenous O6-benzylguanine followed approximately 1 hour later by intravenous carmustine every 6 weeks. Additional cohorts of 3-6 patients are treated with escalating doses of carmustine until dose limiting toxicity (DLT) is observed. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 24-56 patients (12-28 per stratum) will be accrued in 12 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 glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

O6-benzylguanine

Intervention Type

Drug

Intervention Name(s)

carmustine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent, persistent, or progressive glioblastoma multiforme or anaplastic astrocytoma diagnosed by biopsy/resection Evaluable residual disease by MRI or CT scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin within normal limits Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min BUN no greater than 25 mg/dL Pulmonary: DLCO greater than 80% predicted Other: Not pregnant or nursing Fertile patients must use effective contraceptive method during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosourea, procarbazine, or mitomycin) and recovered Endocrine therapy: Concurrent corticosteroid therapy must be stable for at least 1 week prior to study, if clinically possible Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry S. Friedman, MD

Organizational Affiliation

Duke Cancer Institute

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

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