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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.
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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002226 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

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.

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.

Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: SU5416
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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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002226
294A, 5416.003
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SUGEN
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NIH AIDS Clinical Trials Information Service
June 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP