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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect 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 patient...

Gender

ALL

Eligibility 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.