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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003466 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.
Condition | Intervention | Phase |
Brain and Central Nervous System Tumors |
Drug: temozolomide |
Phase II |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Temozolomide |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal |
Estimated Enrollment: | 100 |
Study Start Date: | March 1998 |
OBJECTIVES:
OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).
Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.
Patients are followed every 8-12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.
Ages Eligible for Study: | 4 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:
Patients with optic pathway glioma must also meet the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No other prior or concurrent malignancies except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |||||
Duke Comprehensive Cancer Center | |||||
Durham, North Carolina, United States, 27710 | |||||
United States, Pennsylvania | |||||
Children's Hospital of Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104-4318 |
Duke University |
National Cancer Institute (NCI) |
Study Chair: | Henry S. Friedman, MD | Duke University |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066502, DUMC-1703-04-12R7, DUMC-000693-01-3R1, DUMC-1703-01-94R, DUMC-1502-97-10, DUMC-1569-98-10R1, DUMC-97125, NCI-G98-1469, DUMC-1703-02-9R5 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003466 |
Health Authority: | United States: Federal Government |
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