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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00005931
First received: June 30, 2000
Last updated: June 23, 2005
Last verified: December 2000

June 30, 2000
June 23, 2005
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Complete list of historical versions of study NCT00005931 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Efficacy Study
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.
Both
18 Years and older
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