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OpenTrials
Completed

NCT Number: NCT00002226

Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With 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.

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Key information

Conditions

Sarcoma, Kaposi Blood-Borne Infections Communicable Diseases DNA Virus Infections Genital Diseases HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue RNA Virus Infections Retroviridae Infections Sarcoma Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norris Cancer Ctr / USC, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SU5416

Drug

Sponsors and collaborators

Lead sponsor

SUGEN

Industry

Registry information

Official study title

A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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