Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
NCT ID: NCT00003991
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
360 participants
INTERVENTIONAL
1998-07-31
2011-08-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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aldesleukin
histamine dihydrochloride
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 OR Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: PTT normal Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No class III or IV heart disease No hypotension, severe hypertension, or serious or uncontrolled cardiac dysrhythmia (e.g., ventricular arrhythmias) No acute myocardial infarction within the past 12 months No active uncontrolled angina pectoris No symptomatic arteriosclerotic blood vessel disease Pulmonary: No history of asthma within the past 5 years Other: No other active malignancies except localized basal or squamous cell skin cancer or carcinoma in situ of the cervix HIV negative No prior or active peptic or esophageal ulcer disease No history of hypersensitivity to histamine or histamine products, or severe allergies Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior autologous stem cell transplantation allowed No prior allogeneic stem cell transplantation No other concurrent immunomodulating agents Chemotherapy: See Disease Characteristics Prior induction or consolidation therapy allowed No concurrent chemotherapy Endocrine therapy: At least 24 hours since prior corticosteroids No concurrent steroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent alternative therapy (e.g., laetrile, Brudzinski's treatment, etc.)
18 Years
ALL
No
Sponsors
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Maxim Pharmaceuticals
INDUSTRY
Principal Investigators
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Barbara Berryhill
Role: STUDY_CHAIR
Maxim Pharmaceuticals
Locations
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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
St 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
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Our Lady of Mercy Medical Center
The Bronx, 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
Québec, 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
Besançon, , 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, , Germany
Universitats-Krankenhaus Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Medizinische Klinik und Poliklinik
Heidelberg, , Germany
Staedtische Kliniken Osnabruek
Osnabrück, , Germany
Universitat Rostock
Rostock, , Germany
Caritasklinik St. Theresa
Saarbrücken, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Klinikum der Universitaet Ulm
Ulm, , Germany
Medizinische Poliklinik der Universitat
Würzburg, , Germany
Rambam Medical Center
Haifa, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Rabin Medical Center
Petah 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
Linköping, , Sweden
Lund University Hospital
Lund, , Sweden
Malmo University Hospital
Malmo, , Sweden
Regional Hospital
Örebro, , Sweden
County Hospital (Karnsjukhuset)
Skövde, , Sweden
Huddinge Hospital
Stockholm, , Sweden
Karolinska Hospital
Stockholm, , Sweden
County Hospital/Sundsvall
Sundsvall, , Sweden
County Hospital/Uddevalla
Uddevalla, , Sweden
Umea Universitet
Umeå, , Sweden
University Hospital - Uppsala
Uppsala, , Sweden
County Hospital/Vasteras
Västerås, , 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
Countries
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References
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Buyse M, Michiels S, Squifflet P, Lucchesi KJ, Hellstrand K, Brune ML, Castaigne S, Rowe JM. Leukemia-free survival as a surrogate end point for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission. Haematologica. 2011 Aug;96(8):1106-12. doi: 10.3324/haematol.2010.039131. Epub 2011 May 5.
Buyse M, Squifflet P, Lucchesi KJ, Brune ML, Castaigne S, Rowe JM. Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia. Trials. 2011 Mar 23;12:86. doi: 10.1186/1745-6215-12-86.
Other Identifiers
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MAXIM-MP-MA-0201
Identifier Type: -
Identifier Source: secondary_id
CWRU-MAXI-1998
Identifier Type: -
Identifier Source: secondary_id
CDR0000067196
Identifier Type: -
Identifier Source: org_study_id