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

June 23, 2005 updated by: Cytran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytran

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306A
  • KS-20898-01
  • AMC-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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