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

Sponsor

Cytran (Industry)

Overall Status

Completed

CT.gov ID

NCT00002445

Collaborator

(none)

200

Enrollment

Locations

4.8

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: IM862	Phase 3

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 Design

Study Type:

Interventional

Masking:

Double

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	AIDS Healthcare Foundation	Los Angeles	California	United States	90027
2	LAGLC	Los Angeles	California	United States	90028
3	USC School of Medicine / Norris Cancer Hosp	Los Angeles	California	United States	90033
4	Tower ID Med Associates	Los Angeles	California	United States	90048
5	UCLA Care Ctr	Los Angeles	California	United States	90095
6	UCSD Med Ctr	San Diego	California	United States	92103
7	UCSF - San Francisco Gen Hosp	San Francisco	California	United States	94110
8	Conant Med Ctr	San Francisco	California	United States	94117
9	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
10	BioQuan Research Group	North Miami	Florida	United States	33161
11	Grady Mem Hosp	Atlanta	Georgia	United States	30308
12	Northwestern Univ	Chicago	Illinois	United States	60611
13	Infectious Disease of Indiana	Indianapolis	Indiana	United States	46218
14	Johns Hopkins Oncology	Baltimore	Maryland	United States	21231
15	Massachusetts Gen Hosp	Boston	Massachusetts	United States	02114
16	Boston Med Ctr	Boston	Massachusetts	United States	02118
17	Beth Israel Med Ctr	Boston	Massachusetts	United States	02215
18	Washington Univ School of Medicine	St. Louis	Missouri	United States	63110
19	UMDNJ - New Jersey Med School	Newark	New Jersey	United States	071032757
20	Albert Einstein Comprehensive Ctr	Bronx	New York	United States	10461
21	St Vincents Hosp / Clinical Research Program	New York	New York	United States	10011
22	New York Univ Med Ctr	New York	New York	United States	10016
23	Mem Sloan - Kettering Cancer Ctr	New York	New York	United States	10021
24	Columbia-Presbyterian Hosp	New York	New York	United States	10032
25	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
26	Ohio State Univ	Columbus	Ohio	United States	43210
27	Pennsylvania Oncology and Hematology Associates	Philadelphia	Pennsylvania	United States	19106
28	Vanderbilt Cancer Ctr	Nashville	Tennessee	United States	37232
29	Cytran Inc	Kirkland	Washington	United States	98033
30	Virginia Mason Med Ctr	Seattle	Washington	United States	98101
31	Univ of Washington / Harborview Med Ctr	Seattle	Washington	United States	98104
32	St Vincent's Hosp / Dept of Haematology	Darlinghurst		Australia
33	Alfred Hosp	Prahan		Australia
34	Prince of Wales Hosp	Randwick		Australia
35	Taylors Square Clinic	Sydney		Australia
36	Inst of Tropical Medicine	Antwerpe		Belgium
37	CHU Saint Pierre	Brussels		Belgium
38	BC Cancer Agency	Vancouver	British Columbia	Canada
39	Ottawa General Hospital	Ottawa	Ontario	Canada
40	Sunnybrook Health Science Centre	Toronto	Ontario	Canada
41	Toronto Gen Hosp	Toronto	Ontario	Canada
42	Montreal Gen Hosp / Div of Clin Immuno and Allergy	Montreal	Quebec	Canada