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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 2000
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: Primary Purpose: Treatment
Official Title: A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00002226

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
  More Information

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 Identifier: NCT00002226     History of Changes
Other Study ID Numbers: 294A
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms
Sarcoma, Kaposi
Antineoplastic Agents

Additional relevant MeSH terms:
HIV Infections
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
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
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 processed this record on September 20, 2017