Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

Sponsor

SUGEN (Industry)

Overall Status

Completed

CT.gov ID

NCT00002226

Collaborator

(none)

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: SU5416	N/A

Detailed Description

Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

You may be eligible for this study if you:

Are at least 18 years old.
Are HIV-positive.
Have KS with at least 5 skin lesions.
Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy.
Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

Have had surgery within 4 weeks of study entry.
Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry.
Have pulmonary KS (KS in your lungs).
Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers.
Are allergic to Cremophor.
Have not recovered from previous cancer treatment (chemotherapy, radiotherapy, or immunotherapy).
Are pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norris Cancer Ctr / USC	Los Angeles	California	United States	90033
2	UCLA Care Ctr / Ctr for Hlth Sciences	Los Angeles	California	United States	900951793
3	Saint Francis Mem Hosp / HIV Care Unit	San Francisco	California	United States	94109
4	New York Univ Med Ctr	New York	New York	United States	10016