Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
- Conditions
- Sarcoma, KaposiHIV Infections
- Registration Number
- NCT00002445
- Lead Sponsor
- Cytran
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (42)
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States
LAGLC
🇺🇸Los Angeles, California, United States
USC School of Medicine / Norris Cancer Hosp
🇺🇸Los Angeles, California, United States
Tower ID Med Associates
🇺🇸Los Angeles, California, United States
UCLA Care Ctr
🇺🇸Los Angeles, California, United States
UCSD Med Ctr
🇺🇸San Diego, California, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Conant Med Ctr
🇺🇸San Francisco, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
BioQuan Research Group
🇺🇸North Miami, Florida, United States
Scroll for more (32 remaining)AIDS Healthcare Foundation🇺🇸Los Angeles, California, United States