Clinical trial NCT00002445: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Placebos
Sarcoma, Kaposi
Antineoplastic Agents
Treatment Outcome
Quality of Life
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have AIDS-related Kaposi's sarcoma.
* Have at least 5 skin or mouth sores that do not require chemotherapy.
* Have been taking anti-HIV drugs for at least 8 weeks before study entry with no changes in the regimen.
* Are at least 18 years old.
* Agree to practice effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have an AIDS-related opportunistic infection (except for genital herpes) within 2 weeks of study entry.
* Have had another type of cancer within the past 2 years (except for certain types of skin cancer, cervical cancer, or anal cancer).
* Have a severe chest cold.
* Have certain other serious medical conditions.
* Have received certain medications, including chemotherapy, within the past 4 weeks.
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.

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