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EMD 121974 in Treating Patients With HIV-Related Kaposi's Sarcoma

2014-08-27 03:57:25 | BioPortfolio

Summary

RATIONALE: EMD 121974 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have HIV-related Kaposi's sarcoma.

Description

OBJECTIVES: I. Determine the safety and toxicity of EMD 121974 in patients with HIV related Kaposi's sarcoma. II. Determine the antiangiogenic activity of this drug in these patients. III. Determine the antitumor activity of this drug in these patients. IV. Determine the effect of this drug on CD4 and CD8 cell counts and percentages, and on HIV viral load in these patients. V. Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose escalation study. Patients receive EMD 121974 IV twice a week for four weeks. Courses repeat every 4 weeks in the absence of disease progression. 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 at which no more than 1 of 6 patients experiences dose limiting toxicities. Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 1 year.

Study Design

Primary Purpose: Treatment

Conditions

Sarcoma

Intervention

cilengitide

Location

University of California San Diego Cancer Center
La Jolla
California
United States
92093-0658

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:25-0400

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Medical and Biotech [MESH] Definitions

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An experimental sarcoma of mice.

An experimental sarcoma of rats.

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A family of transforming proteins isolated from retroviruses such as MOUSE SARCOMA VIRUSES. They are viral-derived members of the raf-kinase family of serine-theonine kinases.

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