Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003991
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : November 6, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: aldesleukin Drug: histamine dihydrochloride Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Primary Purpose: Treatment
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 Start Date : July 1998
Actual Study Completion Date : August 2011

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Cytologically confirmed acute myeloid leukemia (AML) in first complete remission (CR) or subsequent CR Less than 5% blasts in normal bone marrow Less than 3 months since last dose of chemotherapy OR Less than 6 months since achieving CR

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003991

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United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
Sidney Kimmel Cancer Center
San Diego, California, United States, 92121
Pacific Hematology/Oncology
San Francisco, California, United States, 94115
United States, Florida
Bethesda Bone Marrow Stem Cell Transplant Institute
Boynton Beach, Florida, United States, 33473
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States, 32209
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Oncology and Hematology Associates
Westwood, Kansas, United States, 66205
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Providence Hospital Cancer Center
Southfield, Michigan, United States, 48075
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Center
Las Vegas, Nevada, United States, 89106
Nevada Medical Group-Internal Medicine
Reno, Nevada, United States, 89502
United States, New Mexico
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
University of Rochester Cancer Center
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
West Clinic, P.C.
Memphis, Tennessee, United States, 38117
Boston Cancer Group
Memphis, Tennessee, United States, 38119
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Cancer Care Institute of South Texas
San Antonio, Texas, United States, 78229
South Texas Cancer Institute
San Antonio, Texas, United States, 78229
Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, NSW 2310
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
NSW Breast Cancer Institute
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Wesley Clinic for Hematology/Oncology
Auchenflower, Queensland, Australia, 4066
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4029
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Mater Public Hospital
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Hanson Center for Cancer Research
Adelaide, South Australia, Australia, 5006
Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
Australia, Victoria
Monash Medical Center
East Bentleigh, Victoria, Australia, 3165
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia, 8006
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Fremantle Hospital
Fremantle, Australia, 6160
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Seaforth Medical Centre
Montreal, Quebec, Canada, H3H 1V4
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Aalborg Hospital
Aalborg, Denmark, 9100
Odense University Hospital
Odense, Denmark, DK-5000
Tallinn Central Hospital
Tallinn, Estonia, 10138
University of Tartu
Tartu, Estonia, EE-2400
Helsinki University Central Hospital
Helsinki, Finland, FIN-0-0029
Kuopio University Hospital
Kuopio, Finland, FIN-7-0211
Tampere University Hospital
Tampere, Finland, 33521
Turku University Central Hospital
Turku, Finland, FIN-2-0521
Centre Hospitalier Regional et Universitaire d'Angers
Angers, France, 49033
CHR de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Hopital Beaujon
Clichy, France, 92118
Hopital Andre Mignot
Le Chesnay, France, 78157
Centre Hospitalier Regional de Lille
Lille, France, 59037
Hopital Edouard Herriot
Lyon, France, 69437
CHR Hotel Dieu
Nantes, France, 44093
Centre Henri Becquerel
Rouen, France, 76038
Zentralklinikum Augsburg
Augsburg, Germany, DOH-8-6156
Universitaetsklinikum Charite
Berlin, Germany, D-10117
Evang. Diakonissenanstalt
Bremen, Germany, D-28239
Medizinische Klinik I
Dresden, Germany, D-01307
Universitaetsklinik und Strahlenklinik - Essen
Essen, Germany, D-45122
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Martin Luther Universitaet
Halle Saale, Germany, DOH-0-6112
Universitats-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Medizinische Klinik und Poliklinik
Heidelberg, Germany, D-69115
Staedtische Kliniken Osnabruek
Osnabruck, Germany, DOH-4-9076
Universitat Rostock
Rostock, Germany, D-18057
Caritasklinik St. Theresa
Saarbrucken, Germany, D-66113
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
Klinikum der Universitaet Ulm
Ulm, Germany, D-89081
Medizinische Poliklinik der Universitat
Wurzburg, Germany, 97070
Rambam Medical Center
Haifa, Israel, 31096
Hadassah University Hospital
Jerusalem, Israel, 91120
Rabin Medical Center
Petach-Tikva, Israel, 49100
Sheba Medical Center
Ramat Gan, Israel, 52621
Kaplan Hospital
Rehovot, Israel, 76100
Tel-Aviv Medical Center-Ichilov Hospital
Tel-Aviv, Israel, 62995
New Zealand
University of Auckland School of Medicine
Auckland, New Zealand, 3
Canterbury Health Laboratories
Christchurch, New Zealand
Waikato Hospital
Hamilton, New Zealand, 2020
Palmerston North Hospital
Palmerston North, New Zealand
Wellington Hospital
Wellington, New Zealand, 2
County Hospital (Malar Hospital)
Eskilstuna, Sweden, 63188
Sahlgrenska University Hospital
Gothenburg (Goteborg), Sweden, S-413 45
County Hospital/Kalmar
Kalmar, Sweden, 39185
Central Hospital
Karlstad, Sweden, 65185
University Hospital of Linkoping
Linkoping, Sweden, S-581 85
Lund University Hospital
Lund, Sweden, SE-22-1 85
Malmo University Hospital
Malmo, Sweden, S-20502
Regional Hospital
Orebro, Sweden, 70185
County Hospital (Karnsjukhuset)
Skovde, Sweden, 54185
Huddinge Hospital
Stockholm, Sweden, S-141 86
Karolinska Hospital
Stockholm, Sweden, S-171 76
County Hospital/Sundsvall
Sundsvall, Sweden, 85283
County Hospital/Uddevalla
Uddevalla, Sweden, 45189
Umea Universitet
Umea, Sweden, S-901 85
University Hospital - Uppsala
Uppsala, Sweden, S-751 85
County Hospital/Vasteras
Vasteras, Sweden, 72189
United Kingdom
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, United Kingdom, B9 5SS
Leeds Teaching Hospital Trust
Leeds, England, United Kingdom, LS1 3EX
Manchester Royal Infirmary
Manchester, England, United Kingdom, M13 9WL
Sponsors and Collaborators
Maxim Pharmaceuticals
Study Chair: Barbara Berryhill Maxim Pharmaceuticals

Publications of Results: Identifier: NCT00003991     History of Changes
Other Study ID Numbers: CDR0000067196
First Posted: June 3, 2004    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: December 2011

Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia in remission

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Histamine phosphate
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action