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
Trial Locations
- Locations (42)
Pennsylvania Oncology and Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Northwestern Univ
🇺🇸Chicago, Illinois, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Beth Israel Med Ctr
🇺🇸Boston, Massachusetts, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Washington / Harborview Med Ctr
🇺🇸Seattle, Washington, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Conant Med Ctr
🇺🇸San Francisco, California, United States
Infectious Disease of Indiana
🇺🇸Indianapolis, Indiana, United States
Vanderbilt Cancer Ctr
🇺🇸Nashville, Tennessee, United States
Cytran Inc
🇺🇸Kirkland, Washington, United States
LAGLC
🇺🇸Los Angeles, California, United States
Grady Mem Hosp
🇺🇸Atlanta, Georgia, United States
USC School of Medicine / Norris Cancer Hosp
🇺🇸Los Angeles, California, United States
Columbia-Presbyterian Hosp
🇺🇸New York, New York, United States
St Vincents Hosp / Clinical Research Program
🇺🇸New York, New York, United States
Johns Hopkins Oncology
🇺🇸Baltimore, Maryland, United States
Washington Univ School of Medicine
🇺🇸St. Louis, Missouri, United States
UCLA Care Ctr
🇺🇸Los Angeles, California, United States
UCSD Med Ctr
🇺🇸San Diego, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Tower ID Med Associates
🇺🇸Los Angeles, California, United States
Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
UMDNJ - New Jersey Med School
🇺🇸Newark, New Jersey, United States
Inst of Tropical Medicine
🇧🇪Antwerpe, Belgium
CHU Saint Pierre
🇧🇪Brussels, Belgium
Alfred Hosp
🇦🇺Prahan, Australia
Prince of Wales Hosp
🇦🇺Randwick, Australia
Toronto Gen Hosp
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
New York Univ Med Ctr
🇺🇸New York, New York, United States
Ohio State Univ
🇺🇸Columbus, Ohio, United States
Virginia Mason Med Ctr
🇺🇸Seattle, Washington, United States
St Vincent's Hosp / Dept of Haematology
🇦🇺Darlinghurst, Australia
Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
Taylors Square Clinic
🇦🇺Sydney, Australia
Montreal Gen Hosp / Div of Clin Immuno and Allergy
🇨🇦Montreal, Quebec, Canada
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
BioQuan Research Group
🇺🇸North Miami, Florida, United States
Albert Einstein Comprehensive Ctr
🇺🇸Bronx, New York, United States
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States