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

NCT ID: NCT00002226

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sarcoma, Kaposi HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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SU5416

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SUGEN

INDUSTRY

Sponsor Role lead

Locations

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Norris Cancer Ctr / USC

Los Angeles, California, United States

Site Status

UCLA Care Ctr / Ctr for Hlth Sciences

Los Angeles, California, United States

Site Status

Saint Francis Mem Hosp / HIV Care Unit

San Francisco, California, United States

Site Status

New York Univ Med Ctr

New York, New York, United States

Site Status

Countries

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United States

References

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Gill P, Arasteh K, Jacobs M, Friedman-Kiel A, Miles S, Gracey S, Hannah A, Langecker P. A multicenter, dose-escalating study in patients with AIDS-related Kaposi's Sarcoma 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29

Reference Type BACKGROUND

Other Identifiers

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5416.003

Identifier Type: -

Identifier Source: secondary_id

294A

Identifier Type: -

Identifier Source: org_study_id