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Spots Global Cancer Trial Database for Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients

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Trial Identification

Brief Title: Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients

Official Title: A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma

Study ID: NCT00002445

Interventions

IM862

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Grady Mem Hosp, Atlanta, Georgia, United States

Northwestern Univ, Chicago, Illinois, United States

Infectious Disease of Indiana, Indianapolis, Indiana, United States

Johns Hopkins Oncology, Baltimore, Maryland, United States

Massachusetts Gen Hosp, Boston, Massachusetts, United States

Boston Med Ctr, Boston, Massachusetts, United States

Beth Israel Med Ctr, Boston, Massachusetts, United States

Washington Univ School of Medicine, St. Louis, Missouri, United States

UMDNJ - New Jersey Med School, Newark, New Jersey, United States

Albert Einstein Comprehensive Ctr, Bronx, New York, United States

St Vincents Hosp / Clinical Research Program, New York, New York, United States

New York Univ Med Ctr, New York, New York, United States

Mem Sloan - Kettering Cancer Ctr, New York, New York, United States

Columbia-Presbyterian Hosp, New York, New York, United States

Case Western Reserve Univ, Cleveland, Ohio, United States

Ohio State Univ, Columbus, Ohio, United States

Pennsylvania Oncology and Hematology Associates, Philadelphia, Pennsylvania, United States

Vanderbilt Cancer Ctr, Nashville, Tennessee, United States

Cytran Inc, Kirkland, Washington, United States

Virginia Mason Med Ctr, Seattle, Washington, United States

Univ of Washington / Harborview Med Ctr, Seattle, Washington, United States

St Vincent's Hosp / Dept of Haematology, Darlinghurst, , Australia

Alfred Hosp, Prahan, , Australia

Prince of Wales Hosp, Randwick, , Australia

Taylors Square Clinic, Sydney, , Australia

Inst of Tropical Medicine, Antwerpe, , Belgium

CHU Saint Pierre, Brussels, , Belgium

BC Cancer Agency, Vancouver, British Columbia, Canada

Ottawa General Hospital, Ottawa, Ontario, Canada

Sunnybrook Health Science Centre, Toronto, Ontario, Canada

Toronto Gen Hosp, Toronto, Ontario, Canada

Montreal Gen Hosp / Div of Clin Immuno and Allergy, Montreal, Quebec, Canada

Contact Details

Name: Parkash Gill

Affiliation:

Role: STUDY_CHAIR

Name: David Scadden

Affiliation:

Role: STUDY_CHAIR

Name: Ariela Noy

Affiliation:

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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