Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

S

Sugen

Status

Completed

Conditions

Sarcoma, Kaposi
HIV Infections

Treatments

Drug: SU5416

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002226
5416.003
294A

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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