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NCT00005931 Clinical Trial

SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment

HIV Infections Clinical Trial

Official title:
A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005931
Other study ID # 310B
Secondary ID SU5416.027
Status Completed
Phase Phase 2
First received June 30, 2000
Last updated June 23, 2005

Study information
Verified date December 2000
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SU5416

Locations
Country Name City State
United States Alison L. Hannah South San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
SUGEN

Country where clinical trial is conducted

United States, 

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