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SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005931
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
June 30, 2000
August 31, 2001
December 9, 2005
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No Changes Posted
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SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment
A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma
The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).
Patients are given SU5416 via twice-weekly intravenous infusions in 4-week treatment cycles. Any patient who has not experienced unacceptable toxicity and who is deemed to be responding to the study drug (no evidence of disease progression) is permitted to continue receiving SU5416 in 4-week treatment cycles (up to a maximum of 1 year of therapy) until that patient experiences either unacceptable toxicity or tumor progression, as defined in the protocol.
Interventional
Phase 2
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: SU5416
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*   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

Patients may be eligible for this study if they:

  • Are at least 18 years old.
  • Have KS.
  • Have taken paclitaxel, DaunoXome, or Doxil for KS and they have either not gotten better or could not tolerate treatment therapy.
  • Have 1 of the following symptoms for KS: 5 lesions (sores), generalized KS-related edema (swelling) without sores, or KS-related edema of the arms and legs.
  • Agree to use an effective method of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  • Are allergic to Cremophor.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00005931
310B
SU5416.027
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SUGEN
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NIH AIDS Clinical Trials Information Service
December 2000

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