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


Phase 3
18 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Parkash Gill

Investigator Role:

Study Chair

Authority:

United States: Food and Drug Administration

Study ID:

306A

NCT ID:

NCT00002445

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Placebos
  • Sarcoma, Kaposi
  • Antineoplastic Agents
  • Treatment Outcome
  • Quality of Life
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
UCLA CARE CtrLos Angeles, California  90095
Univ of Miami School of MedicineMiami, Florida  331361013
Boston Med CtrBoston, Massachusetts  02118
USC School of Medicine / Norris Cancer HospLos Angeles, California  90033
Case Western Reserve UnivCleveland, Ohio  44106
New York Univ Med CtrNew York, New York  10016
Washington Univ School of MedicineSt. Louis, Missouri  63108
UCSF - San Francisco Gen HospSan Francisco, California  94110
Univ of Washington / Harborview Med CtrSeattle, Washington  98104
AIDS Healthcare FoundationLos Angeles, California  90027
LAGLCLos Angeles, California  90028
Tower ID Med AssociatesLos Angeles, California  90048
UCSD Med CtrSan Diego, California  92103
Conant Med CtrSan Francisco, California  94117
BioQuan Research GroupNorth Miami, Florida  33161
Grady Mem HospAtlanta, Georgia  30308
Northwestern UnivChicago, Illinois  60611
Infectious Disease of IndianaIndianapolis, Indiana  46218
Johns Hopkins OncologyBaltimore, Maryland  21231
Beth Israel Med CtrBoston, Massachusetts  02215
Massachusetts Gen HospBoston, Massachusetts  02114
UMDNJ - New Jersey Med SchoolNewark, New Jersey  071032757
Albert Einstein Comprehensive CtrBronx, New York  10461
St Vincents Hosp / Clinical Research ProgramNew York, New York  10011
Columbia-Presbyterian HospNew York, New York  10032
Ohio State UnivColumbus, Ohio  43210
Pennsylvania Oncology and Hematology AssociatesPhiladelphia, Pennsylvania  19106
Vanderbilt Cancer CtrNashville, Tennessee  37232
Cytran IncKirkland, Washington  98033
Virginia Mason Med CtrSeattle, Washington  98101