Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
North American Brain Tumor Consortium National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004868 |
RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: semaxanib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas |
Study Start Date: | February 2000 |
OBJECTIVES: Phase I:
Phase II:
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (no vs yes).
Patients receive SU5416 IV on days 1 and 4 weekly for 4 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD has been determined, additional patients are accrued to the phase II portion of the study. These patients receive SU5416 IV, as in the phase I portion, at the appropriate MTD established in phase I.
Patients are followed for survival.
PROJECTED ACCRUAL: At least 30 patients will be accrued for the phase I dose-escalation portion of this study within 10 months. An additional 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for the phase II portion of this study within 6-8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven supratentorial malignant primary glioma, including:
Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days
Phase II:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Phase I:
Phase II:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
UCSF Cancer Center and Cancer Research Institute | |
San Francisco, California, United States, 94143-0128 | |
United States, Maryland | |
Neuro-Oncology Branch | |
Bethesda, Maryland, United States, 20892 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0752 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15213-3489 | |
United States, Texas | |
Simmons Cancer Center - Dallas | |
Dallas, Texas, United States, 75235-9154 | |
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, 78284-7811 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
Study ID Numbers: | CDR0000067527, NABTC-9902, MSKCC-01045, NCI-00-C-0173 |
Study First Received: | March 7, 2000 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00004868 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult meningioma adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
adult mixed glioma adult grade III meningioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms SU 5416 Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Meningioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |