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LeukemiaPhase 3NCT00003991

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

A Phase 3 study testing aldesleukin and histamine dihydrochloride in people with Leukemia, run by Maxim Pharmaceuticals at 118 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
aldesleukin and histamine dihydrochloride
How many people
360 participants
Where
118 sitesin 12 countries
Study dates
Jul 1998to Aug 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.)

Trial locations and contacts

118 sites in 12 countries.

118 sites in 12 countries

United States32 sites

  • University of New Mexico Cancer Research & Treatment Center

    Albuquerque, New Mexico, 87131

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Bethesda Bone Marrow Stem Cell Transplant Institute

    Boynton Beach, Florida, 33473

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Scripps Clinic

    La Jolla, California, 92037

  • Nevada Cancer Center

    Las Vegas, Nevada, 89106

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • West Clinic, P.C.

    Memphis, Tennessee, 38117

  • Boston Cancer Group

    Memphis, Tennessee, 38119

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73190

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Nevada Medical Group-Internal Medicine

    Reno, Nevada, 89502

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • Cancer Care Institute of South Texas

    San Antonio, Texas, 78229

  • South Texas Cancer Institute

    San Antonio, Texas, 78229

  • Kaiser Permanente-Southern California Permanente Medical Group

    San Diego, California, 92120

  • Sidney Kimmel Cancer Center

    San Diego, California, 92121

  • Pacific Hematology/Oncology

    San Francisco, California, 94115

  • Maine Center for Cancer Medicine and Blood Disorders

    Scarborough, Maine, 04074

  • Providence Hospital Cancer Center

    Southfield, Michigan, 48075

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Our Lady of Mercy Medical Center

    The Bronx, New York, 10466

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • New York Medical College

    Valhalla, New York, 10595

  • Oncology and Hematology Associates

    Westwood, Kansas, 66205

Other trials in United States

Australia16 sites

  • Hanson Center for Cancer Research

    Adelaide, South Australia, 5006

  • Queen Elizabeth Hospital

    Adelaide, South Australia, 5011

  • Wesley Clinic for Hematology/Oncology

    Auchenflower, Queensland, 4066

  • Royal Brisbane Hospital

    Brisbane, Queensland, 4029

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Monash Medical Center

    East Bentleigh, Victoria, 3165

  • Peter MacCallum Cancer Institute

    East Melbourne, Victoria, 8006

  • Fremantle Hospital

    Fremantle, 6160

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Newcastle Mater Misericordiae Hospital

    Newcastle, New South Wales, NSW 2310

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Mater Public Hospital

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010

  • NSW Breast Cancer Institute

    Westmead, New South Wales, 2145

Other trials in Australia

Germany16 sites

  • Zentralklinikum Augsburg

    Augsburg, DOH-8-6156

  • Universitaetsklinikum Charite

    Berlin, D-10117

  • Evang. Diakonissenanstalt

    Bremen, D-28239

  • Medizinische Klinik I

    Dresden, D-01307

  • Universitaetsklinik und Strahlenklinik - Essen

    Essen, D-45122

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Martin Luther Universitaet

    Halle, DOH-0-6112

  • Universitats-Krankenhaus Eppendorf

    Hamburg, D-20246

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Medizinische Klinik und Poliklinik

    Heidelberg, D-69115

  • Staedtische Kliniken Osnabruek

    Osnabrück, DOH-4-9076

  • Universitat Rostock

    Rostock, D-18057

  • Caritasklinik St. Theresa

    Saarbrücken, D-66113

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Klinikum der Universitaet Ulm

    Ulm, D-89081

  • Medizinische Poliklinik der Universitat

    Würzburg, 97070

Other trials in Germany

Sweden16 sites

  • County Hospital (Malar Hospital)

    Eskilstuna, 63188

  • Sahlgrenska University Hospital

    Gothenburg (Goteborg), S-413 45

  • County Hospital/Kalmar

    Kalmar, 39185

  • Central Hospital

    Karlstad, 65185

  • University Hospital of Linkoping

    Linköping, S-581 85

  • Lund University Hospital

    Lund, SE-22-1 85

  • Malmo University Hospital

    Malmö, S-20502

  • Regional Hospital

    Örebro, 70185

  • County Hospital (Karnsjukhuset)

    Skövde, 54185

  • Huddinge Hospital

    Stockholm, S-141 86

  • Karolinska Hospital

    Stockholm, S-171 76

  • County Hospital/Sundsvall

    Sundsvall, 85283

  • County Hospital/Uddevalla

    Uddevalla, 45189

  • Umea Universitet

    Umeå, S-901 85

  • University Hospital - Uppsala

    Uppsala, S-751 85

  • County Hospital/Vasteras

    Västerås, 72189

Other trials in Sweden

Canada8 sites

  • Queen Elizabeth II Health Science Center

    Halifax, Nova Scotia, B3H 2Y9

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Seaforth Medical Centre

    Montreal, Quebec, H3H 1V4

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Ottawa Regional Cancer Center - General Division

    Ottawa, Ontario, K1H 8L6

  • Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

    Québec, Quebec, G1R 2J6

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

France8 sites

  • Centre Hospitalier Regional et Universitaire d'Angers

    Angers, 49033

  • CHR de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Beaujon

    Clichy, 92118

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Hospitalier Regional de Lille

    Lille, 59037

  • Hopital Edouard Herriot

    Lyon, 69437

  • CHR Hotel Dieu

    Nantes, 44093

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

Israel6 sites

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah University Hospital

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Hospital

    Rehovot, 76100

  • Tel-Aviv Medical Center-Ichilov Hospital

    Tel Aviv, 62995

Other trials in Israel

New Zealand5 sites

  • University of Auckland School of Medicine

    Auckland, 3

  • Canterbury Health Laboratories

    Christchurch

  • Waikato Hospital

    Hamilton, 2020

  • Palmerston North Hospital

    Palmerston North

  • Wellington Hospital

    Wellington, 2

Other trials in New Zealand

Finland4 sites

  • Helsinki University Central Hospital

    Helsinki, FIN-0-0029

  • Kuopio University Hospital

    Kuopio, FIN-7-0211

  • Tampere University Hospital

    Tampere, 33521

  • Turku University Central Hospital

    Turku, FIN-2-0521

Other trials in Finland

United Kingdom3 sites

  • Birmingham Heartlands and Solihull NHS Trust (Teaching)

    Birmingham, England, B9 5SS

  • Leeds Teaching Hospital Trust

    Leeds, England, LS1 3EX

  • Manchester Royal Infirmary

    Manchester, England, M13 9WL

Other trials in United Kingdom

Denmark2 sites

  • Aalborg Hospital

    Aalborg, 9100

  • Odense University Hospital

    Odense, DK-5000

Other trials in Denmark

Estonia2 sites

  • Tallinn Central Hospital

    Tallinn, 10138

  • University of Tartu

    Tartu, EE-2400

Other trials in Estonia

About this study

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)

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.

Read the 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.

Conditions
Leukemia
Being tested
aldesleukin, histamine dihydrochloride
Keywords
adult acute myeloid leukemia in remission
Medical subject headings
Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2004 (estimated)
  2. Study startJul 1998
  3. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003991
Sponsor's protocol ID
CDR0000067196
Other IDs
MAXIM-MP-MA-0201, CWRU-MAXI-1998
Status last verified
Dec 2011
First submitted
1 Nov 1999
Last updated
6 Nov 2013
Results posted
No

Publications

  • 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.

    PubMed 21546500

  • 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.

    PubMed 21429214

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aldesleukin and histamine dihydrochloride in people with Leukemia, run by Maxim Pharmaceuticals at 118 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Australia, Germany, Sweden, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

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