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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Skin Neoplasms Sarcoma, Kaposi Antineoplastic Agents |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Skin Neoplasms Protein Kinase Inhibitors Angiogenesis Inhibitors SU 5416 Immunologic Deficiency Syndromes Kaposi Sarcoma Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Infection Protein Kinase Inhibitors Neoplasms, Connective and Soft Tissue Therapeutic Uses Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections RNA Virus Infections Neoplasms by Histologic Type |
Immune System Diseases Growth Substances Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Immunologic Deficiency Syndromes SU 5416 Herpesviridae Infections Virus Diseases Neoplasms HIV Infections Sexually Transmitted Diseases Lentivirus Infections |