Back to resultsSafety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
Primary Purpose
Sarcoma, Kaposi, HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IM862
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring AIDS-Related Opportunistic Infections, Placebos, Sarcoma, Kaposi, Antineoplastic Agents, Treatment Outcome, Quality of Life
Eligibility 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.
Sites / Locations
- AIDS Healthcare Foundation
- LAGLC
- USC School of Medicine / Norris Cancer Hosp
- Tower ID Med Associates
- UCLA Care Ctr
- UCSD Med Ctr
- UCSF - San Francisco Gen Hosp
- Conant Med Ctr
- Univ of Miami School of Medicine
- BioQuan Research Group
- Grady Mem Hosp
- Northwestern Univ
- Infectious Disease of Indiana
- Johns Hopkins Oncology
- Massachusetts Gen Hosp
- Boston Med Ctr
- Beth Israel Med Ctr
- Washington Univ School of Medicine
- UMDNJ - New Jersey Med School
- Albert Einstein Comprehensive Ctr
- St Vincents Hosp / Clinical Research Program
- New York Univ Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Columbia-Presbyterian Hosp
- Case Western Reserve Univ
- Ohio State Univ
- Pennsylvania Oncology and Hematology Associates
- Vanderbilt Cancer Ctr
- Cytran Inc
- Virginia Mason Med Ctr
- Univ of Washington / Harborview Med Ctr
- St Vincent's Hosp / Dept of Haematology
- Alfred Hosp
- Prince of Wales Hosp
- Taylors Square Clinic
- Inst of Tropical Medicine
- CHU Saint Pierre
- BC Cancer Agency
- Ottawa General Hospital
- Sunnybrook Health Science Centre
- Toronto Gen Hosp
- Montreal Gen Hosp / Div of Clin Immuno and Allergy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002445
Brief Title
Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
Official Title
A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2001
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cytran
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Placebos, Sarcoma, Kaposi, Antineoplastic Agents, Treatment Outcome, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IM862
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parkash Gill
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Scadden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ariela Noy
Official's Role
Study Chair
Facility Information:
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
LAGLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
USC School of Medicine / Norris Cancer Hosp
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Tower ID Med Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Care Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSD Med Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Conant Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
BioQuan Research Group
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Grady Mem Hosp
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern Univ
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Infectious Disease of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46218
Country
United States
Facility Name
Johns Hopkins Oncology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Massachusetts Gen Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington Univ School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UMDNJ - New Jersey Med School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032757
Country
United States
Facility Name
Albert Einstein Comprehensive Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
St Vincents Hosp / Clinical Research Program
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia-Presbyterian Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State Univ
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pennsylvania Oncology and Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Vanderbilt Cancer Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Cytran Inc
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Virginia Mason Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Univ of Washington / Harborview Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
St Vincent's Hosp / Dept of Haematology
City
Darlinghurst
Country
Australia
Facility Name
Alfred Hosp
City
Prahan
Country
Australia
Facility Name
Prince of Wales Hosp
City
Randwick
Country
Australia
Facility Name
Taylors Square Clinic
City
Sydney
Country
Australia
Facility Name
Inst of Tropical Medicine
City
Antwerpe
Country
Belgium
Facility Name
CHU Saint Pierre
City
Brussels
Country
Belgium
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Gen Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Gen Hosp / Div of Clin Immuno and Allergy
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
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