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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003466 |
Purpose
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 |
| 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.
Eligibility| 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:
Contacts and Locations| 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 | |
| Study Chair: | Henry S. Friedman, MD | Duke University |
More Information
| 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 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003466 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor adult mixed glioma childhood mixed glioma adult pilocytic astrocytoma adult subependymoma recurrent childhood cerebral astrocytoma adult brain stem glioma |
recurrent childhood brain stem glioma untreated childhood brain stem glioma recurrent childhood visual pathway and hypothalamic glioma untreated childhood visual pathway and hypothalamic glioma adult oligodendroglioma adult diffuse astrocytoma |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Neuroectodermal Tumors Neoplasms |
Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |