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

Phase 1

Terminated

• Conditions: Sarcoma
• Interventions: Drug: cilengitide

• Registration Number: NCT00006222
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Phase I trial to study the effectiveness of EMD 121974 in treating patients who have HIV-related Kaposi's sarcoma. EMD 121974 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

Detailed 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 Timeline

• Study Start: 2000-09
• Study First Submitted: 2000-09-11
• Primary Completion: 2001-03
• Study Completion: 2001-03
• Status Verified: 2001-04
• Study First Submitted QC: 2004-05-25
• Study First Posted: 2004-05-26
• Last Update Submitted: 2013-05-31
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	cilengitide	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.

Trial Locations

Locations (3)

Vanderbilt Cancer Center; 🇺🇸 Nashville, Tennessee, United States

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States