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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: | NCT00112866 |
RATIONALE: Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Giving cilengitide before and after surgery may be an effective treatment for glioblastoma multiforme.
PURPOSE: This phase II trial is studying how well cilengitide works in treating patients who are undergoing surgery for recurrent or progressive glioblastoma multiforme.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: cilengitide Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of EMD 121974 for Recurrent Glioblastoma : A Clinical Trial With Tissue Correlates of Response |
Estimated Enrollment: | 44 |
Study Start Date: | April 2005 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups for the preoperative treatment component.
Preoperative Treatment
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per preoperative treatment group) 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 confirmed intracranial glioblastoma multiforme (GBM)
Recurrent disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No more than 3 prior treatments for GBM (1 initial treatment; and treatment for 2 relapses)
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
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 | |
M. D. Anderson Cancer Center at University of Texas | |
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 Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Chair: | Mark R. Gilbert, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000428409, NABTC-0302 |
Study First Received: | June 2, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00112866 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma adult glioblastoma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |