Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00003991
- Lead Sponsor
- Maxim Pharmaceuticals
- Brief Summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission.
PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (118)
Tampere University Hospital
🇫🇮Tampere, Finland
Turku University Central Hospital
🇫🇮Turku, Finland
Tel-Aviv Medical Center-Ichilov Hospital
🇮🇱Tel-Aviv, Israel
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
Nevada Medical Group-Internal Medicine
🇺🇸Reno, Nevada, United States
St. Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Manchester Royal Infirmary
🇬🇧Manchester, England, United Kingdom
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Oncology and Hematology Associates
🇺🇸Westwood, Kansas, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Sidney Kimmel Cancer Center
🇺🇸San Diego, California, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of New Mexico Cancer Research & Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Our Lady of Mercy Medical Center
🇺🇸Bronx, New York, United States
Newcastle Mater Misericordiae Hospital
🇦🇺Newcastle, New South Wales, Australia
Peter MacCallum Cancer Institute
🇦🇺East Melbourne, Victoria, Australia
Maine Center for Cancer Medicine and Blood Disorders
🇺🇸Scarborough, Maine, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
West Clinic, P.C.
🇺🇸Memphis, Tennessee, United States
Wesley Clinic for Hematology/Oncology
🇦🇺Auchenflower, Queensland, Australia
Kuopio University Hospital
🇫🇮Kuopio, Finland
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Monash Medical Center
🇦🇺East Bentleigh, Victoria, Australia
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Klinikum der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
Hopital Edouard Herriot
🇫🇷Lyon, France
Martin Luther Universitaet
🇩🇪Halle Saale, Germany
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Queen Elizabeth II Health Science Center
🇨🇦Halifax, Nova Scotia, Canada
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Boston Cancer Group
🇺🇸Memphis, Tennessee, United States
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
NSW Breast Cancer Institute
🇦🇺Westmead, New South Wales, Australia
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
🇨🇦Quebec City, Quebec, Canada
Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Aalborg Hospital
🇩🇰Aalborg, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Hanson Center for Cancer Research
🇦🇺Adelaide, South Australia, Australia
Royal Brisbane Hospital
🇦🇺Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Queen Elizabeth Hospital
🇦🇺Adelaide, South Australia, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Seaforth Medical Centre
🇨🇦Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Fremantle Hospital
🇦🇺Fremantle, Australia
Ottawa Regional Cancer Center - General Division
🇨🇦Ottawa, Ontario, Canada
Lund University Hospital
🇸🇪Lund, Sweden
Universitats-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Medizinische Klinik und Poliklinik
🇩🇪Heidelberg, Germany
Wellington Hospital
🇳🇿Wellington, New Zealand
County Hospital (Karnsjukhuset)
🇸🇪Skovde, Sweden
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Rambam Medical Center
🇮🇱Haifa, Israel
Hadassah University Hospital
🇮🇱Jerusalem, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Kaplan Hospital
🇮🇱Rehovot, Israel
Hopital Beaujon
🇫🇷Clichy, France
Huddinge Hospital
🇸🇪Stockholm, Sweden
County Hospital/Uddevalla
🇸🇪Uddevalla, Sweden
County Hospital/Vasteras
🇸🇪Vasteras, Sweden
Staedtische Kliniken Osnabruek
🇩🇪Osnabruck, Germany
County Hospital/Kalmar
🇸🇪Kalmar, Sweden
Leeds Teaching Hospital Trust
🇬🇧Leeds, England, United Kingdom
Universitat Rostock
🇩🇪Rostock, Germany
Central Hospital
🇸🇪Karlstad, Sweden
Caritasklinik St. Theresa
🇩🇪Saarbrucken, Germany
Regional Hospital
🇸🇪Orebro, Sweden
University Hospital - Uppsala
🇸🇪Uppsala, Sweden
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Pacific Hematology/Oncology
🇺🇸San Francisco, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Care Institute of South Texas
🇺🇸San Antonio, Texas, United States
South Texas Cancer Institute
🇺🇸San Antonio, Texas, United States
University Hospital of Linkoping
🇸🇪Linkoping, Sweden
Malmo University Hospital
🇸🇪Malmo, Sweden
Karolinska Hospital
🇸🇪Stockholm, Sweden
County Hospital/Sundsvall
🇸🇪Sundsvall, Sweden
Umea Universitet
🇸🇪Umea, Sweden
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
Bethesda Bone Marrow Stem Cell Transplant Institute
🇺🇸Boynton Beach, Florida, United States
University of Florida Health Science Center - Jacksonville
🇺🇸Jacksonville, Florida, United States
Providence Hospital Cancer Center
🇺🇸Southfield, Michigan, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
University of Tartu
🇪🇪Tartu, Estonia
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Centre Hospitalier Regional de Lille
🇫🇷Lille, France
CHR Hotel Dieu
🇫🇷Nantes, France
Centre Henri Becquerel
🇫🇷Rouen, France
Zentralklinikum Augsburg
🇩🇪Augsburg, Germany
Evang. Diakonissenanstalt
🇩🇪Bremen, Germany
Medizinische Klinik I
🇩🇪Dresden, Germany
Universitaetsklinikum Charite
🇩🇪Berlin, Germany
Universitaetsklinik und Strahlenklinik - Essen
🇩🇪Essen, Germany
Medizinische Poliklinik der Universitat
🇩🇪Wurzburg, Germany
Rabin Medical Center
🇮🇱Petach-Tikva, Israel
Klinikum der Universitaet Ulm
🇩🇪Ulm, Germany
Waikato Hospital
🇳🇿Hamilton, New Zealand
Canterbury Health Laboratories
🇳🇿Christchurch, New Zealand
University of Auckland School of Medicine
🇳🇿Auckland, New Zealand
County Hospital (Malar Hospital)
🇸🇪Eskilstuna, Sweden
Palmerston North Hospital
🇳🇿Palmerston North, New Zealand
Sahlgrenska University Hospital
🇸🇪Gothenburg (Goteborg), Sweden
Birmingham Heartlands and Solihull NHS Trust (Teaching)
🇬🇧Birmingham, England, United Kingdom
Mater Public Hospital
🇦🇺South Brisbane, Queensland, Australia
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States