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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000763 |
To assess toxicity and determine the MTD of intravenous TNP-470 administered weekly in patients with AIDS-related Kaposi's sarcoma. To assess pharmacokinetics and tumor response of the drug.
Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease.
Condition | Intervention | Phase |
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Sarcoma, Kaposi HIV Infections |
Drug: TNP-470 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
Official Title: | A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma |
Estimated Enrollment: | 42 |
Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease.
Patients are entered at 7 escalating dose levels of TNP-470. (PER AMENDMENT 9/3/96: dose maximum level changed.) Four patients treated at a given dose level must receive at least 4 weeks of therapy before escalation in subsequent cohorts proceeds. If 50 percent of patients at a given dose level experience dose-limiting toxicity, the previous dose is defined as the MTD and an additional two patients are treated at the MTD. Patients receive treatment for 12 weeks, followed by 2 weeks of rest, followed by an additional 12 weeks of treatment. Patients are followed for 12 weeks post-treatment.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Required in patients with CD4 count < 200 cells/mm3:
Aerosolized pentamidine, trimethoprim/sulfamethoxazole, or dapsone as PCP prophylaxis.
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
PER AMENDMENT 9/3/96:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
PER AMENDMENT 9/3/96:
Prior Medication:
Excluded within 4 weeks prior to study entry:
Excluded within 6 months prior to study entry:
Unwilling to refrain from unprotected sexual contact or other activities that may result in HIV re-infection.
United States, California | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Beth Israel Deaconess Med Ctr | |
Boston, Massachusetts, United States, 02215 | |
Boston Med Ctr | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
SUNY / State Univ of New York | |
Syracuse, New York, United States, 13210 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
Albany Med College / Division of HIV Medicine A158 | |
Albany, New York, United States, 122083479 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Gill PS | |
Study Chair: | Dezube B |
Study ID Numbers: | ACTG 215 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000763 |
Health Authority: | United States: Federal Government |
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents |
Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi O-(chloroacetylcarbamoyl)fumagillol 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 Immune System Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Infection Antibiotics, Antineoplastic |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Lentivirus Infections Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents |