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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	SUGEN
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002226

Purpose

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	Intervention
Sarcoma, Kaposi HIV Infections	Drug: SU5416

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Cancer HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: Semaxanib SU 5416

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002226

Locations

United States, California
UCLA Care Ctr / Ctr for Hlth Sciences
Los Angeles, California, United States, 900951793
Norris Cancer Ctr / USC
Los Angeles, California, United States, 90033
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, United States, 94109
United States, New York
New York Univ Med Ctr
New York, New York, United States, 10016

Sponsors and Collaborators

SUGEN

More Information

Publications:

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

ClinicalTrials.gov Identifier:	NCT00002226 History of Changes
Other Study ID Numbers:	294A, 5416.003
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Skin Neoplasms
Sarcoma, Kaposi
Antineoplastic Agents

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections

DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
Parasitic Diseases
SU 5416
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on February 13, 2012