Carmustine in Treating Patients With Recurrent Malignant Glioma
NCT ID: NCT00004028
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1996-09-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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carmustine
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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Alessandro Olivi, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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NABTT-101-9601
Identifier Type: -
Identifier Source: secondary_id
JHOC-NABTT-101-9601
Identifier Type: -
Identifier Source: secondary_id
NCI-T96-0052H
Identifier Type: -
Identifier Source: secondary_id
CDR0000065129
Identifier Type: -
Identifier Source: org_study_id
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