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.
Interventional
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
Parkash Gill
Study Chair
United States: Food and Drug Administration
306A
NCT00002445
Name | Location |
---|---|
Mem Sloan - Kettering Cancer Ctr | New York, New York 10021 |
UCLA CARE Ctr | Los Angeles, California 90095 |
Univ of Miami School of Medicine | Miami, Florida 331361013 |
Boston Med Ctr | Boston, Massachusetts 02118 |
USC School of Medicine / Norris Cancer Hosp | Los Angeles, California 90033 |
Case Western Reserve Univ | Cleveland, Ohio 44106 |
New York Univ Med Ctr | New York, New York 10016 |
Washington Univ School of Medicine | St. Louis, Missouri 63108 |
UCSF - San Francisco Gen Hosp | San Francisco, California 94110 |
Univ of Washington / Harborview Med Ctr | Seattle, Washington 98104 |
AIDS Healthcare Foundation | Los Angeles, California 90027 |
LAGLC | Los Angeles, California 90028 |
Tower ID Med Associates | Los Angeles, California 90048 |
UCSD Med Ctr | San Diego, California 92103 |
Conant Med Ctr | San Francisco, California 94117 |
BioQuan Research Group | North Miami, Florida 33161 |
Grady Mem Hosp | Atlanta, Georgia 30308 |
Northwestern Univ | Chicago, Illinois 60611 |
Infectious Disease of Indiana | Indianapolis, Indiana 46218 |
Johns Hopkins Oncology | Baltimore, Maryland 21231 |
Beth Israel Med Ctr | Boston, Massachusetts 02215 |
Massachusetts Gen Hosp | Boston, Massachusetts 02114 |
UMDNJ - New Jersey Med School | Newark, New Jersey 071032757 |
Albert Einstein Comprehensive Ctr | Bronx, New York 10461 |
St Vincents Hosp / Clinical Research Program | New York, New York 10011 |
Columbia-Presbyterian Hosp | New York, New York 10032 |
Ohio State Univ | Columbus, Ohio 43210 |
Pennsylvania Oncology and Hematology Associates | Philadelphia, Pennsylvania 19106 |
Vanderbilt Cancer Ctr | Nashville, Tennessee 37232 |
Cytran Inc | Kirkland, Washington 98033 |
Virginia Mason Med Ctr | Seattle, Washington 98101 |