Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors
Intervention: carmustine (Drug); polifeprosan 20 with carmustine implant (Drug); chemotherapy (Procedure); surgery (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Henry S. Friedman, MD, Study Chair, Affiliation: Duke University
Summary
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.
Clinical Details
Official title:
Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
Study design: Interventional, 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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: April 9, 2007
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