Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma|
Patients are stratified by CD4 count, viral load, and prior systemic chemotherapy. Patients are randomized equally to receive either IM862 or placebo given intranasally every other day. Patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy. Quality of life is assessed before treatment, then every month for 6 months. At the end of the 6-month study evaluation period, patients with PR/CR (responders) remain on study and continue blinded treatment for an additional 6 months. For patients with stable disease (non-responders), the treatment assignment is unblinded and off-study IM862 compassionate use is offered for 6 months, regardless of treatment group. For patients with documented progressive disease (treatment failure), the treatment assignment is unblinded and off-study IM862 is offered for 6 months to any patient in the placebo group. For treatment failures in the IM862 group, IM862 is stopped and the patient is allowed other therapy options.
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|Study Chair:||Parkash Gill|
|Study Chair:||David Scadden|
|Study Chair:||Ariela Noy|