Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors
This phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma. Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping blood flow to the cancer
PRIMARY OBJECTIVES:
I. Determine the dose-limiting toxicity, maximum feasible dose, and recommended phase II
dose of cilengitide (EMD 121974) in patients with advanced solid tumors or lymphoma.
II. Determine the safety and tolerability of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this drug in these patients. II. Determine the
antineoplastic activity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every
4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
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 2 of 3 or 2 of 6 patients
experience dose-limiting toxicity.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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