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Sponsored by: |
SUGEN |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002226 |
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.
Condition | Intervention |
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Sarcoma, Kaposi HIV Infections |
Drug: SU5416 |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma |
Estimated Enrollment: | 30 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, California | |
UCLA Care Ctr / Ctr for Hlth Sciences | |
Los Angeles, California, United States, 900951793 | |
Norris Cancer Ctr / USC | |
Los Angeles, California, United States, 90033 | |
Saint Francis Mem Hosp / HIV Care Unit | |
San Francisco, California, United States, 94109 | |
United States, New York | |
New York Univ Med Ctr | |
New York, New York, United States, 10016 |
Study ID Numbers: | 294A, 5416.003 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002226 |
Health Authority: | United States: Food and Drug Administration |
Skin Neoplasms Sarcoma, Kaposi Antineoplastic Agents |
Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Skin Neoplasms SU 5416 Soft tissue sarcomas Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Infection |
Protein Kinase Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Lentivirus Infections Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents |