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


N/A
18 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

294A

NCT ID:

NCT00002226

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Skin Neoplasms
  • Sarcoma, Kaposi
  • Antineoplastic Agents
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location
New York Univ Med Ctr New York, New York  10016
UCLA Care Ctr / Ctr for Hlth Sciences Los Angeles, California  900951793
Norris Cancer Ctr / USC Los Angeles, California  90033
Saint Francis Mem Hosp / HIV Care Unit San Francisco, California  94109