A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma

Launched by ANDERSON CLINICAL RESEARCH · Aug 30, 2001

Keywords

ClinConnect Summary

Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active.

Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • HIV positive status and histologic confirmation of KS.
• • CD4 count \> 200 mm3 (required of one-half of patients).
• • Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions.
• • Acceptable organ system function.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.
• Prior Medication:
• Excluded:
• • Systemic therapy for KS within 30 days.
• • Local or topical therapy for KS indicative lesions within 60 days.
• • Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.
• Required:
• • Approved antiretroviral therapy.