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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:
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
History of Changes
  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: Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005931

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

No publications provided

ClinicalTrials.gov Identifier: NCT00005931     History of Changes
Other Study ID Numbers: 310B, SU5416.027
Study First Received: June 30, 2000
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
 DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
Parasitic Diseases
SU 5416
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on February 21, 2013