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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002226

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: June 2000

History of Changes

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:

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

Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma Kaposi Sarcoma

U.S. FDA Resources

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


Estimated Enrollment:	30

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, California
Norris Cancer Ctr / USC
Los Angeles, California, United States, 90033
UCLA Care Ctr / Ctr for Hlth Sciences
Los Angeles, California, United States, 900951793
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 Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms	Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Semaxinib Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016

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