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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002226
Other study ID # 294A
Secondary ID 5416.003
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date June 2000
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SU5416


Locations

Country Name City State
United States Norris Cancer Ctr / USC Los Angeles California
United States UCLA Care Ctr / Ctr for Hlth Sciences Los Angeles California
United States New York Univ Med Ctr New York New York
United States Saint Francis Mem Hosp / HIV Care Unit San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
SUGEN

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

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