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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002226
Enrollment
30
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sarcoma, Kaposi

Keywords

Skin Neoplasms, Sarcoma, Kaposi, Antineoplastic Agents

Brief summary

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.

Detailed 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.

Interventions

DRUGSU5416

Sponsors

SUGEN
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026