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A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma Clinical research trials and A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma. A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma  A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - AZT, ddI, ddC, or d4T provided patients have received at least 2 weeks of this therapy prior to study entry. (Combination ddI/ddC is not permitted.) - MAI prophylaxis. Required in patients with CD4 count < 200 cells/mm3: Aerosolized pentamidine, trimethoprim/sulfamethoxazole, or dapsone as PCP prophylaxis. Patients must have: - HIV infection. - Cutaneous Kaposi's sarcoma. - Life expectancy of at least 3 months. - Consent of parent or guardian if under 18 years of age. NOTE: - This protocol is considered suitable for prison populations. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Peripheral neuropathy (grade 2 or worse). - Underlying severe or life-threatening infection with bacterial, viral, fungal, or protozoal pathogens. - Known hypersensitivity to TNP-470, fumagillin, or known related compounds. PER AMENDMENT 9/3/96: - Cataracts. Concurrent Medication: Excluded: - Combination therapy with ddI/ddC (although these drugs may be administered alone or in combination with AZT). - Anticonvulsive medication. - Steroids. - Antineoplastic drugs. - Interferons. - Systemic or topical anti-Kaposi's sarcoma agents or regimens. - Suramin. - Aspirin. - Warfarin. - Heparin (including heparin flushes). - Nonsteroidal anti-inflammatory drugs. - Investigational status drugs. Patients with the following prior conditions are excluded: - History of substantial non-iatrogenic bleeding disorders. - History of tumor or malignancies other than Kaposi's sarcoma, with the exception of completely resected basal cell skin carcinoma or in situ cervical carcinoma. - History of seizures within the past 10 years. PER AMENDMENT 9/3/96: - History of cataracts. Prior Medication: Excluded within 4 weeks prior to study entry: - Steroids. - Antineoplastic drugs. - Interferons. - Systemic or topical anti-Kaposi's sarcoma agents or regimens. Excluded within 6 months prior to study entry: - Suramin. Unwilling to refrain from unprotected sexual contact or other activities that may result in HIV re-infection.
Total Enrollment: 42
Location and Contact Information:
Overall Study Official:
GillPS, Study Chair,
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, California, 900331079
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Additional Information:
Study ID Numbers: ACTG 215;
Study Start Date:
Record last reviewed: November 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000763
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2. HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
3. Metabolism and Body Shape of Healthy Children and Children with Chronic Infections
4. Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
5. A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
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A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
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