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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002445 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Safety Study

Condition ^ICMJE

Sarcoma, Kaposi
HIV Infections

Intervention ^ICMJE

Drug: IM862

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada

Administrative Information

NCT ID ^ICMJE

NCT00002445

Responsible Party

Study ID Numbers ^ICMJE

306A, KS-20898-01, AMC-013

Study Sponsor ^ICMJE

Cytran

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

June 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP