Carmustine in Treating Patients With Recurrent Malignant Glioma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carmustine Procedure: conventional surgery |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA |
| Study Start Date: | September 1996 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3295 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Pennsylvania | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| Study Chair: | Alessandro Olivi, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004028 History of Changes |
| Other Study ID Numbers: | CDR0000065129, NABTT-101-9601, JHOC-NABTT-101-9601, NCI-T96-0052H |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013