A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
Data Collection
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.42 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
Northwestern University CRS
Chicago, United StatesBmc Actg Crs
Boston, United StatesBeth Israel Deaconess - East Campus A0102 CRS
Boston, United States