A Phase 1/2 interventional study of cilengitide in Brain and Central Nervous System Tumors, sponsored by New Approaches to Brain Tumor Therapy Consortium. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by New Approaches to Brain Tumor Therapy Consortium · Phase 1/2, Interventional, and Treatment
RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma.
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6-12 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A minimum of 6 patients will be accrued for phase I of this study within 2-3 months. A total of 23-38 patients will be accrued for phase II of this study within 5-10 months.
538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.
Browse Nervous System Neoplasms studies →New Approaches to Brain Tumor Therapy Consortium is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy and/or chemotherapy
Eligible subtypes:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is completed, as verified in Apr 2003. You cannot join it, but the record below documents what was studied.
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New Approaches to Brain Tumor Therapy Consortium