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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: June 24, 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
  Purpose
The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).

Condition Intervention Phase
Sarcoma, Kaposi HIV Infections Drug: SU5416 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory 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:
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.
  Eligibility

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

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.
  Contacts and Locations
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): NCT00005931


Locations
United States, California
Alison L. Hannah
South San Francisco, California, United States, 94080
Sponsors and Collaborators
SUGEN
  More Information

ClinicalTrials.gov Identifier: NCT00005931     History of Changes
Other Study ID Numbers: 310B
SU5416.027
First Submitted: June 30, 2000
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: December 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents
Enzyme Inhibitors
SU 5416
Protein-Tyrosine Kinase

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