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



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

For Condition: HIV Infections,Sarcoma, Kaposi
Status: Completed
Sponsor(s): SUGEN ,
Synopsis: The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 30

Location and Contact Information:

Alison L. Hannah
San Francisco,  California,  94080
United States
 


Additional Information:
Study ID Numbers:  310B;  SU5416.027
Study Start Date: 
Record last reviewed: December 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005931

Other Sarcoma, Kaposi Studies:
1. A Study of HIV Levels During Pregnancy and After Childbirth

2. A Study of BufferGel in Women

3. The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs

4. A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

5. HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs

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