Multi-Center, Randomized Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy With Subcutaneous Maxamine (Histamine Dihydrochloride) Plus Proleukin (Interleukin-2) Versus No Treatment (Standard of Care) in Patients With Acute Myeloid Leukemia in First or Subsequent Complete Remission (CR)
OBJECTIVES: I. Compare the efficacy of interleukin-2 plus histamine dihydrochloride
(Maxamine) vs no further therapy in prolonging the leukemia free survival in patients with
acute myeloid leukemia in first or subsequent complete remission (CR) following
consolidation therapy. II. Compare the relapse rate, overall survival, and quality of life
in this patient population treated with interleukin-2 plus Maxamine vs no further therapy.
III. Compare the remission inversion rate in patients in subsequent CR with this treatment
regimen vs no further therapy.
OUTLINE: This is a randomized, open label, parallel, multicenter study. Patients are
stratified according to complete remission (first vs subsequent). Patients are randomized to
one of two treatment arms. Arm I: Following consolidation chemotherapy or autologous stem
cell transplantation, patients receive interleukin-2 subcutaneously followed by histamine
dihydrochloride subcutaneously over 5-7 minutes twice daily on days 1-21. Treatment repeats
every 6 weeks for 3 courses and then every 9 weeks for 7 courses in the absence of disease
relapse or unacceptable toxicity. Arm II: Patients receive no further therapy following
consolidation chemotherapy or autologous stem cell transplantation. Quality of life is
assessed prior to study, and at visits 6, 7, 10, 11, 16, 17, and 22. Patients are followed
for relapse and survival every 3 months for 2.5 years.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Barbara Berryhill
Study Chair
Maxim Pharmaceuticals
United States: Federal Government
CDR0000067196
NCT00003991
July 1998
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Henry Ford Hospital | Detroit, Michigan 48202 |
New York Medical College | Valhalla, New York 10595 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Scripps Clinic | La Jolla, California 92037 |
University of New Mexico Cancer Research & Treatment Center | Albuquerque, New Mexico 87131 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Boston Cancer Group | Memphis, Tennessee 38119 |
Sidney Kimmel Cancer Center | San Diego, California 92121 |
Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
South Texas Cancer Institute | San Antonio, Texas 78229 |
Providence Hospital Cancer Center | Southfield, Michigan 48075 |
Our Lady of Mercy Medical Center | Bronx, New York 10466 |
Baylor University Medical Center | Dallas, Texas 75246 |
Nevada Cancer Center | Las Vegas, Nevada 89109 |
Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
Cancer Care Institute of South Texas | San Antonio, Texas 78229 |
University of Florida Health Science Center - Jacksonville | Jacksonville, Florida 32209 |
Oncology and Hematology Associates | Westwood, Kansas 66205 |
Pacific Hematology/Oncology | San Francisco, California 94115 |
Bethesda Bone Marrow Stem Cell Transplant Institute | Boynton Beach, Florida 33473 |
Nevada Medical Group-Internal Medicine | Reno, Nevada 89502 |
West Clinic, P.C. | Memphis, Tennessee 38117 |