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Carmustine in Treating Patients With Recurrent Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carmustine
conventional surgery
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

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 anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult ependymoblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Pathologically confirmed recurrent malignant glioma for which surgery is indicated Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal Renal: Creatinine less than 1.5 times normal BUN less than 2.5 times normal Protein no greater than 3 g/dL No gross hematuria Other: No hypersensitivity to nitrosoureas Not pregnant Fertile patients must use effective contraception No concurrent life threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy during first 8 weeks of study Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) No concurrent chemotherapy during first 8 weeks of study Endocrine therapy: Not specified Radiotherapy: Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required No concurrent radiotherapy or brachytherapy during first 4 weeks of study Surgery: Prior cytoreductive surgery for supratentorial brain tumor required Biopsy alone not sufficient Other: No concurrent investigational therapy during first 8 weeks of study

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Emory University Hospital - Atlanta
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Massachusetts General Hospital Cancer Center
  • Henry Ford Hospital
  • Comprehensive Cancer Center at Wake Forest University
  • University of Pennsylvania Cancer Center
  • University of Texas Health Science Center at San Antonio

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
February 6, 2009
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004028
Brief Title
Carmustine in Treating Patients With Recurrent Malignant Glioma
Official Title
PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
Study Type
Interventional

2. Study Status

Record Verification Date
January 1999
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
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 I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.
Detailed Description
OBJECTIVES: Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma. OUTLINE: This is a dose escalation study. All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity. Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study. Patients are followed 3, 6, and 12 months after implantation. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

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 anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult ependymoblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed recurrent malignant glioma for which surgery is indicated Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal Renal: Creatinine less than 1.5 times normal BUN less than 2.5 times normal Protein no greater than 3 g/dL No gross hematuria Other: No hypersensitivity to nitrosoureas Not pregnant Fertile patients must use effective contraception No concurrent life threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy during first 8 weeks of study Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) No concurrent chemotherapy during first 8 weeks of study Endocrine therapy: Not specified Radiotherapy: Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required No concurrent radiotherapy or brachytherapy during first 4 weeks of study Surgery: Prior cytoreductive surgery for supratentorial brain tumor required Biopsy alone not sufficient Other: No concurrent investigational therapy during first 8 weeks of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Olivi, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3295
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12721262
Citation
Olivi A, Grossman SA, Tatter S, Barker F, Judy K, Olsen J, Bruce J, Hilt D, Fisher J, Piantadosi S; New Approaches to Brain Tumor Therapy CNS Consortium. Dose escalation of carmustine in surgically implanted polymers in patients with recurrent malignant glioma: a New Approaches to Brain Tumor Therapy CNS Consortium trial. J Clin Oncol. 2003 May 1;21(9):1845-9. doi: 10.1200/JCO.2003.09.041.
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Carmustine in Treating Patients With Recurrent Malignant Glioma

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