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

Sponsor:	Cytran
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002445

Purpose

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.

Condition	Intervention	Phase
Sarcoma, Kaposi HIV Infections	Drug: IM862	Phase III

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
Official Title:	A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma

Resource links provided by NLM:

MedlinePlus related topics: AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

200

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002445

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Locations

United States, California
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
UCSD Med Ctr
San Diego, California, United States, 92103
Conant Med Ctr
San Francisco, California, United States, 94117
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Tower ID Med Associates
Los Angeles, California, United States, 90048
UCLA Care Ctr
Los Angeles, California, United States, 90095
LAGLC
Los Angeles, California, United States, 90028
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
BioQuan Research Group
North Miami, Florida, United States, 33161
United States, Georgia
Grady Mem Hosp
Atlanta, Georgia, United States, 30308
United States, Illinois
Northwestern Univ
Chicago, Illinois, United States, 60611
United States, Indiana
Infectious Disease of Indiana
Indianapolis, Indiana, United States, 46218
United States, Maryland
Johns Hopkins Oncology
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Beth Israel Med Ctr
Boston, Massachusetts, United States, 02215
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington Univ School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
UMDNJ - New Jersey Med School
Newark, New Jersey, United States, 071032757
United States, New York
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
New York Univ Med Ctr
New York, New York, United States, 10016
St Vincents Hosp / Clinical Research Program
New York, New York, United States, 10011
Albert Einstein Comprehensive Ctr
Bronx, New York, United States, 10461
Columbia-Presbyterian Hosp
New York, New York, United States, 10032
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Ohio State Univ
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
United States, Tennessee
Vanderbilt Cancer Ctr
Nashville, Tennessee, United States, 37232
United States, Washington
Virginia Mason Med Ctr
Seattle, Washington, United States, 98101
Univ of Washington / Harborview Med Ctr
Seattle, Washington, United States, 98104
Cytran Inc
Kirkland, Washington, United States, 98033
Australia
Alfred Hosp
Prahan, Australia
Taylors Square Clinic
Sydney, Australia
Prince of Wales Hosp
Randwick, Australia
St Vincent's Hosp / Dept of Haematology
Darlinghurst, Australia
Belgium
CHU Saint Pierre
Brussels, Belgium
Inst of Tropical Medicine
Antwerpe, Belgium
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada
Toronto Gen Hosp
Toronto, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Canada, Quebec
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec, Canada

Sponsors and Collaborators

Cytran

Investigators

Study Chair:	Parkash Gill
Study Chair:	David Scadden
Study Chair:	Ariela Noy

More Information

No publications provided

Study ID Numbers:	306A, KS-20898-01, AMC-013
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002445 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Placebos
Sarcoma, Kaposi

Antineoplastic Agents
Treatment Outcome
Quality of Life

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Infection
Immunologic Deficiency Syndromes
Herpesviridae Infections

Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms
HIV Infections
Sexually Transmitted Diseases
Neoplasms, Vascular Tissue
Sarcoma
Lentivirus Infections
DNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 25, 2009