CompletedPhase 1

A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma

United States42 participants

Plain-language summary

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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 substantia…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00000763

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Sarcoma, Kaposi trials