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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002445
• Other study ID #: 306A
• Secondary ID: KS-20898-01AMC-0
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00003879

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• IM862

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cytran

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,