Spots Global Cancer Trial Database for Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
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Trial Identification
Brief Title: Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
Official Title: 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)
Study ID: NCT00003991
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
Arizona Cancer Center, Tucson, Arizona, United States
Scripps Clinic, La Jolla, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Kaiser Permanente-Southern California Permanente Medical Group, San Diego, California, United States
Sidney Kimmel Cancer Center, San Diego, California, United States
Pacific Hematology/Oncology, San Francisco, California, United States
Bethesda Bone Marrow Stem Cell Transplant Institute, Boynton Beach, Florida, United States
University of Florida Health Science Center - Jacksonville, Jacksonville, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Oncology and Hematology Associates, Westwood, Kansas, United States
Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine, United States
Henry Ford Hospital, Detroit, Michigan, United States
Providence Hospital Cancer Center, Southfield, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Nevada Cancer Center, Las Vegas, Nevada, United States
Nevada Medical Group-Internal Medicine, Reno, Nevada, 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
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
New York Medical College, Valhalla, New York, United States
Ireland Cancer Center, Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
West Clinic, P.C., Memphis, Tennessee, United States
Boston Cancer Group, Memphis, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
Cancer Care Institute of South Texas, San Antonio, Texas, United States
South Texas Cancer Institute, San Antonio, Texas, United States
Liverpool Hospital, Liverpool, New South Wales, Australia
Newcastle Mater Misericordiae Hospital, Newcastle, New South Wales, Australia
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
St. Vincent's Hospital, Sydney, New South Wales, Australia
NSW Breast Cancer Institute, Westmead, New South Wales, Australia
Wesley Clinic for Hematology/Oncology, Auchenflower, Queensland, Australia
Royal Brisbane Hospital, Brisbane, Queensland, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Mater Public Hospital, South Brisbane, Queensland, Australia
Hanson Center for Cancer Research, Adelaide, South Australia, Australia
Queen Elizabeth Hospital, Adelaide, South Australia, Australia
Monash Medical Center, East Bentleigh, Victoria, Australia
Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Fremantle Hospital, Fremantle, , Australia
Vancouver General Hospital, Vancouver, British Columbia, Canada
Queen Elizabeth II Health Science Center, Halifax, Nova Scotia, Canada
London Health Sciences Centre, London, Ontario, Canada
Ottawa Regional Cancer Center - General Division, Ottawa, Ontario, Canada
Seaforth Medical Centre, Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec, Quebec City, Quebec, Canada
Royal University Hospital, Saskatoon, Saskatchewan, Canada
Aalborg Hospital, Aalborg, , Denmark
Odense University Hospital, Odense, , Denmark
Tallinn Central Hospital, Tallinn, , Estonia
University of Tartu, Tartu, , Estonia
Helsinki University Central Hospital, Helsinki, , Finland
Kuopio University Hospital, Kuopio, , Finland
Tampere University Hospital, Tampere, , Finland
Turku University Central Hospital, Turku, , Finland
Centre Hospitalier Regional et Universitaire d'Angers, Angers, , France
CHR de Besancon - Hopital Jean Minjoz, Besancon, , France
Hopital Beaujon, Clichy, , France
Hopital Andre Mignot, Le Chesnay, , France
Centre Hospitalier Regional de Lille, Lille, , France
Hopital Edouard Herriot, Lyon, , France
CHR Hotel Dieu, Nantes, , France
Centre Henri Becquerel, Rouen, , France
Zentralklinikum Augsburg, Augsburg, , Germany
Universitaetsklinikum Charite, Berlin, , Germany
Evang. Diakonissenanstalt, Bremen, , Germany
Medizinische Klinik I, Dresden, , Germany
Universitaetsklinik und Strahlenklinik - Essen, Essen, , Germany
Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany
Martin Luther Universitaet, Halle Saale, , Germany
Universitats-Krankenhaus Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Medizinische Klinik und Poliklinik, Heidelberg, , Germany
Staedtische Kliniken Osnabruek, Osnabruck, , Germany
Universitat Rostock, Rostock, , Germany
Caritasklinik St. Theresa, Saarbrucken, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Klinikum der Universitaet Ulm, Ulm, , Germany
Medizinische Poliklinik der Universitat, Wurzburg, , Germany
Rambam Medical Center, Haifa, , Israel
Hadassah University Hospital, Jerusalem, , Israel
Rabin Medical Center, Petach-Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Kaplan Hospital, Rehovot, , Israel
Tel-Aviv Medical Center-Ichilov Hospital, Tel-Aviv, , Israel
University of Auckland School of Medicine, Auckland, , New Zealand
Canterbury Health Laboratories, Christchurch, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Palmerston North Hospital, Palmerston North, , New Zealand
Wellington Hospital, Wellington, , New Zealand
County Hospital (Malar Hospital), Eskilstuna, , Sweden
Sahlgrenska University Hospital, Gothenburg (Goteborg), , Sweden
County Hospital/Kalmar, Kalmar, , Sweden
Central Hospital, Karlstad, , Sweden
University Hospital of Linkoping, Linkoping, , Sweden
Lund University Hospital, Lund, , Sweden
Malmo University Hospital, Malmo, , Sweden
Regional Hospital, Orebro, , Sweden
County Hospital (Karnsjukhuset), Skovde, , Sweden
Huddinge Hospital, Stockholm, , Sweden
Karolinska Hospital, Stockholm, , Sweden
County Hospital/Sundsvall, Sundsvall, , Sweden
County Hospital/Uddevalla, Uddevalla, , Sweden
Umea Universitet, Umea, , Sweden
University Hospital - Uppsala, Uppsala, , Sweden
County Hospital/Vasteras, Vasteras, , Sweden
Birmingham Heartlands and Solihull NHS Trust (Teaching), Birmingham, England, United Kingdom
Leeds Teaching Hospital Trust, Leeds, England, United Kingdom
Manchester Royal Infirmary, Manchester, England, United Kingdom
Contact Details
Name: Barbara Berryhill
Affiliation: Maxim Pharmaceuticals
Role: STUDY_CHAIR
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