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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002445
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 2001
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
UCLA Care Ctr
Los Angeles, California, United States, 90095
LAGLC
Los Angeles, California, United States, 90028
Tower ID Med Associates
Los Angeles, California, United States, 90048
UCSD Med Ctr
San Diego, California, United States, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Conant Med Ctr
San Francisco, California, United States, 94117
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
Albert Einstein Comprehensive Ctr
Bronx, New York, United States, 10461
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
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
Cytran Inc
Kirkland, Washington, United States, 98033
Univ of Washington / Harborview Med Ctr
Seattle, Washington, United States, 98104
Virginia Mason Med Ctr
Seattle, Washington, United States, 98101
Australia
St Vincent's Hosp / Dept of Haematology
Darlinghurst, Australia
Alfred Hosp
Prahan, Australia
Prince of Wales Hosp
Randwick, Australia
Taylors Square Clinic
Sydney, Australia
Belgium
Inst of Tropical Medicine
Antwerpe, Belgium
CHU Saint Pierre
Brussels, 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

ClinicalTrials.gov Identifier: NCT00002445     History of Changes
Obsolete Identifiers: NCT00003879
Other Study ID Numbers: 306A, KS-20898-01, AMC-013
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014