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Sponsors and Collaborators: |
North American Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006025 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: irinotecan hydrochloride Drug: temozolomide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I-II Trial of CPT-11 and Temozolomide (Temodar) in Patients With Recurrent Malignant Glioma |
Study Start Date: | November 2000 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., phenytoin, phenobarbital, carbamazepine, or primidone) (yes vs no).
In phase I of the study, patients receive oral temozolomide on days 1-5 and irinotecan IV over 90 minutes on days 1 and 14. Treatment continues every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients concurrently on EIAEDs undergo dose escalation of irinotecan. Cohorts of 3 to 6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.
In phase II of the study, patients receive the same treatment as in phase I at the MTD.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months until progression, and then every 4 months for survival.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for phase I within 10 months and 48 patients will be accrued for phase II within 6-8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial malignant primary glioma of one of the following subtypes:
Measurable recurrent or residual primary disease by MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Phase II:
Radiotherapy:
Surgery:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-6220 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Chair: | Wai-Kwan A. Yung, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000068037, NABTC-9907, UCLA-0006095 |
Study First Received: | July 5, 2000 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00006025 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
adult mixed glioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Irinotecan Central Nervous System Neoplasms Temozolomide Camptothecin Recurrence Brain Neoplasms |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Antineoplastic Agents, Phytogenic |