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

NCT00002445 | Completed Phase 3

• 3 other identifiers: 306AKS-20898-01AMC-013
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 42

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.

Conditions

Sarcoma, Kaposi; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Placebos; Sarcoma, Kaposi; Antineoplastic Agents; Treatment Outcome; Quality of Life

Interventions

IM862 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cytran: lead

Study Sites (42)

AIDS Healthcare Foundation

Los Angeles, California, 90027, United States

Location

LAGLC

Los Angeles, California, 90028, United States

Location

USC School of Medicine / Norris Cancer Hosp

Los Angeles, California, 90033, United States

Location

Tower ID Med Associates

Los Angeles, California, 90048, United States

Location

UCLA Care Ctr

Los Angeles, California, 90095, United States

Location

UCSD Med Ctr

San Diego, California, 92103, United States

Location

UCSF - San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

Conant Med Ctr

San Francisco, California, 94117, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

BioQuan Research Group

North Miami, Florida, 33161, United States

Location

Grady Mem Hosp

Atlanta, Georgia, 30308, United States

Location

Northwestern Univ

Chicago, Illinois, 60611, United States

Location

Infectious Disease of Indiana

Indianapolis, Indiana, 46218, United States

Location

Johns Hopkins Oncology

Baltimore, Maryland, 21231, United States

Location

Massachusetts Gen Hosp

Boston, Massachusetts, 02114, United States

Location

Boston Med Ctr

Boston, Massachusetts, 02118, United States

Location

Beth Israel Med Ctr

Boston, Massachusetts, 02215, United States

Location

Washington Univ School of Medicine

St Louis, Missouri, 63110, United States

Location

UMDNJ - New Jersey Med School

Newark, New Jersey, 071032757, United States

Location

St Vincents Hosp / Clinical Research Program

New York, New York, 10011, United States

Location

New York Univ Med Ctr

New York, New York, 10016, United States

Location

Mem Sloan - Kettering Cancer Ctr

New York, New York, 10021, United States

Location

Columbia-Presbyterian Hosp

New York, New York, 10032, United States

Location

Albert Einstein Comprehensive Ctr

The Bronx, New York, 10461, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Ohio State Univ

Columbus, Ohio, 43210, United States

Location

Pennsylvania Oncology and Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Vanderbilt Cancer Ctr

Nashville, Tennessee, 37232, United States

Location

Cytran Inc

Kirkland, Washington, 98033, United States

Location

Virginia Mason Med Ctr

Seattle, Washington, 98101, United States

Location

Univ of Washington / Harborview Med Ctr

Seattle, Washington, 98104, United States

Location

St Vincent's Hosp / Dept of Haematology

Darlinghurst, Australia

Location

Alfred Hosp

Prahan, Australia

Location

Prince of Wales Hosp

Randwick, Australia

Location

Taylors Square Clinic

Sydney, Australia

Location

Inst of Tropical Medicine

Antwerp, Belgium

Location

CHU Saint Pierre

Brussels, Belgium

Location

BC Cancer Agency

Vancouver, British Columbia, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Location

Toronto Gen Hosp

Toronto, Ontario, Canada

Location

Montreal Gen Hosp / Div of Clin Immuno and Allergy

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Sarcoma, Kaposi; HIV Infections; AIDS-Related Opportunistic Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections

Study Officials

• Parkash Gill

  STUDY CHAIR

• David Scadden

  STUDY CHAIR

• Ariela Noy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2001-06

Locations

AU (4); CA (5); US (31); BE (2)