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

This study is currently recruiting patients.

Sponsored by

Cytran Inc

Purpose

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. Patients will be assigned randomly (like tossing a coin) to take either IM862 or placebo (inactive liquid) as a nasal spray every other day for 6 months. This is a double-blind study, meaning neither the patient nor his/her doctor will know which study drug he/she is taking. Patients will be seen at the clinic once every 4 weeks for 6 months to evaluate the safety and effectiveness of the drug and their quality of life. At the end of the 6 months, their KS will be evaluated. Depending on whether it has improved, stayed the same, or gotten worse, patients may have the option of continuing on IM862 for another 6 months. 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. 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 Type and Design: Treatment; Double-Blind Method, Placebo-Controlled Trial, Randomized Control Study

Official Title: A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients with Muco-cutaneous AIDS Associated Kaposi's Sarcoma

Further Study Details: To compare the complete and partial response rates and the impact of treatment on safety and quality of life between IM862 and placebo in patients with mucocutaneous AIDS-related Kaposi's sarcoma (KS).  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 (nonresponders), 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.  

Eligibility

Ages Eligible for Study:  18 Years  and above ,  Genders Eligible for Study:  Both Inclusion Criteria

Patients must have: 1. HIV infection, documented by ELISA and Western blot or other federally approved, licensed HIV test. 2. Histologically proven AIDS-related KS. 3. At least 5 measurable lesions involving the skin or oral cavity, not requiring chemotherapy. 4. World Health Organization (WHO) performance status 0-2. 5. Life expectancy of at least 10 weeks.

Required: Stable antiretroviral therapy for at least 8 weeks prior to study. Allowed: Investigational new drug expanded antiretroviral therapy access.

Not breast-feeding

Negative pregnancy test within 14 days of study entry

Abstinence or effective method of birth control / contraception including oral contraceptives during the study

Absolute Neutrophil Count >= 750 /mm3

Alkaline Phosphatase <= 3 x ULN ULN (Upper Limit of Normal)

Bilirubin < 2 x ULN < 3.5 x ULN for indinavir sulfate if direct bilirubin normal.

Platelet Count >= 75000 /mm3

SGPT(ALT) <= 3 x ULN

SGOT(AST) <= 3 x ULN

Exclusion Criteria

Patients with the following prior conditions are excluded: 1. An acute AIDS-defining opportunistic infection, except for genital herpes, within 2 weeks of study entry. 2. Other malignancies within the past 2 years, except basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the anus.

Patients with the following symptoms or conditions are excluded: 1. Symptomatic visceral disease. 2. Severe lymphedema secondary to KS. 3. Acute or severe upper respiratory congestion or distress with a history of rhinorrhea.

Excluded: 1. Interferon, interleukin, immunomodulator therapy (e.g., thalidomide), systemic chemotherapy, or glucocorticoid therapy within 4 weeks of study entry. 2. Any prior IM862 use.

Excluded: 1. Interleukin-2 or interferon. 2. Chemotherapy. 3. Panretin. 4. Investigational drugs, except investigational new drug expanded antiretroviral therapy access.

Excluded: Radiotherapy to any indicator lesion within 4 weeks of study entry.

Excluded: Drug or alcohol abuse.

Location and Contact Information

BC, Canada

BC Cancer Agency, 600 W 10th Ave    Vancouver,   BC,   Canada; Recruiting

Stephanie Monkman       604-877-6098    smonkman@bccancer.bc.ca 

ON, Canada

Ottawa General Hospital, 501 Smyth Rd / Room G12   Ottawa,   ON,   Canada; Recruiting

Nanci Hawley-Foss       613-737-8879    Nhawley-foss@ogh.on.ca 

ON, Canada

Toronto Gen Hosp, 101 College St    Toronto,   ON,   Canada; Recruiting

Andrea Foster       416-340-4239    afoster@torhosp.toronto.on.ca 

ON, Canada

Sunnybrook Health Science Centre, 2075 Bayview Ave / Room A417   Toronto,   ON,    Canada; Recruiting

Miriam Bast       416-480-6110    Miriam.bast@swchsc.on.ca 

QC, Canada

Montreal Gen Hosp / Div of Clin Immuno and Allergy, 1650 Cedar Ave / Room A5-140   Montreal,   QC,    Canada; Recruiting

Marie D'Astous       514-937-6011    mdastous@is.muhc.mcgill.ca 

California

UCSF - San Francisco Gen Hosp, 635 Potrero Ave   San Francisco,   California,   94110,    United States; Recruiting

Lawrence Marsco       415-476-9296    lmarsco@php.ucsf.edu 

California

USC School of Medicine / Norris Cancer Hosp, 1441 East Lake Ave   Los Angeles,   California,    90033,   United States; Recruiting

Byron Espina       323-865-0371    espina@hsc.usc.edu 

California

UCSD Med Ctr, 200 West Arbor Dr    San Diego,   California,   92103,   United States; Recruiting

Kim Smith       619-543-3679    k9smith@uscd.edu 

California

Conant Med Ctr, 350 Parnassus Ave / Suite 808   San Francisco,   California,   94117,    United States; Recruiting

Chris Eden       415-759-4126    Chris@marcusconantmd.com 

Florida

Univ of Miami School of Medicine, 1800 Northwest 10th Ave / P O Box 016960   Miami,   Florida,    33136-1013,   United States; Recruiting

Leslie Thompson       305-243-3838    umacru@gate.net 

Illinois

Northwestern Univ, 233 East Erie St    Chicago,   Illinois,   60611,   United States; Recruiting

Lisa Volini       312-908-2250    l-volini@nwu.edu 

Maryland

Johns Hopkins Oncology, Bunting/Blaustein Cancer Research Ctr   1650 Orleans St, Rm 389-M    Baltimore,   Maryland,   21231,   United States; Recruiting

Linda Post       410-614-5541    lpost@jhmi.edu 

Massachusetts

Boston Med Ctr, 818 Harrison Ave    Boston,   Massachusetts,   02118,   United States; Recruiting

Ruth Haivanis       617-414-5404    ruth.haivanis@bmc.org 

Massachusetts

Beth Israel Med Ctr, 330 Brookline Ave    Kirstein 158   Boston,   Massachusetts,    02215,   United States; Recruiting

JoAnn Proper       617-667-9925    jproper@caregroup.harvard.edu 

Massachusetts

Massachusetts Gen Hosp, 75 Blossom Ct    Boston,   Massachusetts,   02114,   United States; Recruiting

Kathleen Shea       617-724-9190    kshea@partners.org 

Missouri

Washington Univ School of Medicine, 4940 Parkview Place   Div of Oncology, Rm 10042   St Louis,   Missouri,   63110,   United States; Recruiting

Lee Ratner       314-362-8836    lratner@imgate.wustl.edu 

New Jersey

UMDNJ - New Jersey Med School, 185 South Orange Ave   Newark,   New Jersey,   07103-2757,    United States; Recruiting

Tracie Saunders       973-972-2163    saundetk@umdnj.edu 

New York

Mem Sloan - Kettering Cancer Ctr, 1275 York Ave   New York,   New York,   10021,   United States; Recruiting

Andrea Martelli       212-639-7161    martella@mskcc.org 

New York

New York Univ Med Ctr, 562 First Ave / Room H158   New York,   New York,   10016,    United States; Recruiting

Tricia Spoto       212-263-5244    spoto01@popmail.med.nyu.edu 

New York

St Vincents Hosp / Clinical Research Program, 36 7th Ave / Suite 415   New York,   New York,    10011,   United States; Recruiting

Margaret Granville       212-604-2246    magsvh@aol.com 

New York

Albert Einstein Comprehensive Ctr, Montefiore Cancer Ctr - Weiler Div   1825 Eastchester Rd    Bronx,   New York,   10461,   United States; Recruiting

Una Hopkins       718-904-2321    uhopkins@montefiore.org 

Ohio

Case Western Reserve Univ, 11100 Euclid Ave   Cleveland,   Ohio,   44106,   United States; Recruiting

Karen Coviello       216-844-8622    karen.coviello@uhhs.com 

Ohio

Ohio State Univ, James Cancer Hosp    300 W 10th Ave, Rm 1216   Columbus,   Ohio,    43210,   United States; Recruiting

Paulette Snider       614-293-7362    snider-1@medctr.osu.edu 

Pennsylvania

Pennsylvania Oncology and Hematology Associates, 230 West Washington Square   Philadelphia,    Pennsylvania,   19106,   United States; Recruiting

Helen Cohen       215-829-6292    honeyc1@juno.com 

Tennessee

Vanderbilt Cancer Ctr, Clinical Trials Office   2611 Westend Blvd, Suite 340   Nashville,    Tennessee,   37232,   United States; Recruiting

Kelly Willenberg       615-936-5812    kelly.willenberg@mcmail.vanderbilt.edu  

Washington

Virginia Mason Med Ctr, 1100 9th Ave    Seattle,   Washington,   98101,   United States; Recruiting

Cheryl Weaver       206-223-6835    Crgclw@vmmc.org 

Washington

Univ of Washington / Harborview Med Ctr, 325 Ninth Ave   Seattle,   Washington,   98104,    United States; Recruiting

Diane DeBoghasian       206-616-2394    dderbo@u.washington.edu 

Washington

Cytran Inc, 10230 NE Points Dr Suite 530   Kirkland,   Washington,   98033,   United States; Recruiting

Unspecified       425-889-8822   

Study chairs or principal investigators

Parkash S. Gill,  Study Chair

David T. Scadden,  Co-Chair

Ariela Noy,  Co-Chair

More Information

Study ID Numbers  306A;   KS-20898-01; AMC-013

NLM Identifier  NCT00002445

Recruitment status verified  June 7, 2000

Last Updated  September 8, 1999

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