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

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ClinicalTrials.gov Identifier: NCT00002226
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Sarcoma, Kaposi HIV Infections Drug: SU5416 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2000

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