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

November 5, 2013 updated by: Maxim Pharmaceuticals

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maxim Pharmaceuticals

Investigators

  • Study Chair: Barbara Berryhill, Maxim Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion

December 7, 2022

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 2, 2004

First Posted (Estimate)

June 3, 2004

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067196
  • MAXIM-MP-MA-0201
  • CWRU-MAXI-1998

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe