- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003467
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Henry S. Friedman, MD, Duke University
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Carmustine
Other Study ID Numbers
- 1706
- DUMC-1706-02-9R5
- DUMC-1706-01-9R4
- DUMC-000693-00-4
- DUMC-1509-97-10
- DUMC-1568-98-10R1
- DUMC-1706-00-9R3
- DUMC-97131
- NCI-G98-1470
- CDR0000066503 (Other Identifier: NCI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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