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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002445
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002445

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Sponsors and Collaborators
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Study Chair: Parkash Gill
Study Chair: David Scadden
Study Chair: Ariela Noy
Layout table for additonal information Identifier: NCT00002445    
Obsolete Identifiers: NCT00003879
Other Study ID Numbers: 306A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2001
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Sarcoma, Kaposi
Antineoplastic Agents
Treatment Outcome
Quality of Life
Additional relevant MeSH terms:
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Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue