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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00313729 |
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: temozolomide Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma |
Estimated Enrollment: | 120 |
Study Start Date: | May 1999 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:
Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma
PATIENT CHARACTERISTICS:
No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 |
Study Chair: | Susan M. Chang, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Responsible Party: | UCSF Medical Center at Parnassus ( Susan Marina Chang ) |
Study ID Numbers: | CDR0000448883, UCSF-99102, BTRC-9902, UCSF-H7858-16278-07 |
Study First Received: | April 11, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00313729 |
Health Authority: | Unspecified |
adult oligodendroglioma adult mixed glioma adult diffuse astrocytoma adult pilocytic astrocytoma adult pineal gland astrocytoma |
Neuroectodermal Tumors Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma |
Glioma Central Nervous System Neoplasms Temozolomide Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |