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

NCT00003991 | Completed Phase 3

• 3 other identifiers: CDR0000067196MAXIM-MP-MA-0201CWRU-MAXI-1998
• Study Type: interventional
• Target: 360
• Locations: 12 countries
• Sites: 118

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.

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remission

Interventions

aldesleukin BIOLOGICAL

histamine dihydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Maxim Pharmaceuticals: lead

Study Sites (118)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

Sidney Kimmel Cancer Center

San Diego, California, 92121, United States

Location

Pacific Hematology/Oncology

San Francisco, California, 94115, United States

Location

Bethesda Bone Marrow Stem Cell Transplant Institute

Boynton Beach, Florida, 33473, United States

Location

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Oncology and Hematology Associates

Westwood, Kansas, 66205, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Providence Hospital Cancer Center

Southfield, Michigan, 48075, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nevada Cancer Center

Las Vegas, Nevada, 89106, United States

Location

Nevada Medical Group-Internal Medicine

Reno, Nevada, 89502, United States

Location

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Our Lady of Mercy Medical Center

The Bronx, New York, 10466, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

West Clinic, P.C.

Memphis, Tennessee, 38117, United States

Location

Boston Cancer Group

Memphis, Tennessee, 38119, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Cancer Care Institute of South Texas

San Antonio, Texas, 78229, United States

Location

South Texas Cancer Institute

San Antonio, Texas, 78229, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Newcastle Mater Misericordiae Hospital

Newcastle, New South Wales, NSW 2310, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

NSW Breast Cancer Institute

Westmead, New South Wales, 2145, Australia

Location

Wesley Clinic for Hematology/Oncology

Auchenflower, Queensland, 4066, Australia

Location

Royal Brisbane Hospital

Brisbane, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Mater Public Hospital

South Brisbane, Queensland, 4101, Australia

Location

Hanson Center for Cancer Research

Adelaide, South Australia, 5006, Australia

Location

Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

Location

Monash Medical Center

East Bentleigh, Victoria, 3165, Australia

Location

Peter MacCallum Cancer Institute

East Melbourne, Victoria, 8006, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Fremantle Hospital

Fremantle, 6160, Australia

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Queen Elizabeth II Health Science Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Ottawa Regional Cancer Center - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Seaforth Medical Centre

Montreal, Quebec, H3H 1V4, Canada

Location

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Aalborg Hospital

Aalborg, 9100, Denmark

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

University of Tartu

Tartu, EE-2400, Estonia

Location

Helsinki University Central Hospital

Helsinki, FIN-0-0029, Finland

Location

Kuopio University Hospital

Kuopio, FIN-7-0211, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Turku University Central Hospital

Turku, FIN-2-0521, Finland

Location

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Centre Hospitalier Regional de Lille

Lille, 59037, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Zentralklinikum Augsburg

Augsburg, DOH-8-6156, Germany

Location

Universitaetsklinikum Charite

Berlin, D-10117, Germany

Location

Evang. Diakonissenanstalt

Bremen, D-28239, Germany

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Universitaetsklinik und Strahlenklinik - Essen

Essen, D-45122, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Martin Luther Universitaet

Halle, DOH-0-6112, Germany

Location

Universitats-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Medizinische Klinik und Poliklinik

Heidelberg, D-69115, Germany

Location

Staedtische Kliniken Osnabruek

Osnabrück, DOH-4-9076, Germany

Location

Universitat Rostock

Rostock, D-18057, Germany

Location

Caritasklinik St. Theresa

Saarbrücken, D-66113, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Klinikum der Universitaet Ulm

Ulm, D-89081, Germany

Location

Medizinische Poliklinik der Universitat

Würzburg, 97070, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Kaplan Hospital

Rehovot, 76100, Israel

Location

Tel-Aviv Medical Center-Ichilov Hospital

Tel Aviv, 62995, Israel

Location

University of Auckland School of Medicine

Auckland, 3, New Zealand

Location

Canterbury Health Laboratories

Christchurch, New Zealand

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

Palmerston North Hospital

Palmerston North, New Zealand

Location

Wellington Hospital

Wellington, 2, New Zealand

Location

County Hospital (Malar Hospital)

Eskilstuna, 63188, Sweden

Location

Sahlgrenska University Hospital

Gothenburg (Goteborg), S-413 45, Sweden

Location

County Hospital/Kalmar

Kalmar, 39185, Sweden

Location

Central Hospital

Karlstad, 65185, Sweden

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

Lund University Hospital

Lund, SE-22-1 85, Sweden

Location

Malmo University Hospital

Malmo, S-20502, Sweden

Location

Regional Hospital

Örebro, 70185, Sweden

Location

County Hospital (Karnsjukhuset)

Skövde, 54185, Sweden

Location

Huddinge Hospital

Stockholm, S-141 86, Sweden

Location

Karolinska Hospital

Stockholm, S-171 76, Sweden

Location

County Hospital/Sundsvall

Sundsvall, 85283, Sweden

Location

County Hospital/Uddevalla

Uddevalla, 45189, Sweden

Location

Umea Universitet

Umeå, S-901 85, Sweden

Location

University Hospital - Uppsala

Uppsala, S-751 85, Sweden

Location

County Hospital/Vasteras

Västerås, 72189, Sweden

Location

Birmingham Heartlands and Solihull NHS Trust (Teaching)

Birmingham, England, B9 5SS, United Kingdom

Location

Leeds Teaching Hospital Trust

Leeds, England, LS1 3EX, United Kingdom

Location

Manchester Royal Infirmary

Manchester, England, M13 9WL, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 21546500 RESULT

• 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.

  PMID: 21429214 RESULT

MeSH Terms

Conditions

Leukemia

Interventions

aldesleukin; Histamine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Barbara Berryhill

  Maxim Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 3, 2004
• Study Start: July 1, 1998
• Study Completion: August 1, 2011
• Last Updated: November 6, 2013

Record last verified: 2011-12

Locations

AU (16); IL (6); SE (16); US (32); GB (3); ES (2); DK (2); DE (16); NZ (5); CA (8); FI (4); FR (8)