Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: aldesleukin Drug: histamine dihydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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) |
| Estimated Enrollment: | 360 |
| Study Start Date: | July 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.)
Contacts and Locations
Hide Study Locations| 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 | |
| Sidney Kimmel Cancer Center | |
| San Diego, California, United States, 92121 | |
| Kaiser Permanente-Southern California Permanente Medical Group | |
| San Diego, California, United States, 92120 | |
| 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 | |
| Boston Cancer Group | |
| Memphis, Tennessee, United States, 38119 | |
| West Clinic, P.C. | |
| Memphis, Tennessee, United States, 38117 | |
| 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 | |
| Princess Alexandra Hospital | |
| Brisbane, Queensland, Australia, 4102 | |
| Royal Brisbane Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Mater Public Hospital | |
| South Brisbane, Queensland, Australia, 4101 | |
| Australia, South Australia | |
| Queen Elizabeth Hospital | |
| Adelaide, South Australia, Australia, 5011 | |
| Hanson Center for Cancer Research | |
| Adelaide, South Australia, Australia, 5006 | |
| 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 | |
| Australia | |
| 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 | |
| Hopital Du Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Seaforth Medical Centre | |
| Montreal, Quebec, Canada, H3H 1V4 | |
| Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Canada, Saskatchewan | |
| Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Denmark | |
| Aalborg Hospital | |
| Aalborg, Denmark, 9100 | |
| Odense University Hospital | |
| Odense, Denmark, DK-5000 | |
| Estonia | |
| Tallinn Central Hospital | |
| Tallinn, Estonia, 10138 | |
| University of Tartu | |
| Tartu, Estonia, EE-2400 | |
| Finland | |
| 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 | |
| France | |
| 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 | |
| Germany | |
| 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 | |
| Israel | |
| 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 | |
| Sweden | |
| 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 | |
| Study Chair: | Barbara Berryhill | Maxim Pharmaceuticals |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003991 History of Changes |
| Other Study ID Numbers: | CDR0000067196, MAXIM-MP-MA-0201, CWRU-MAXI-1998 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 17, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult acute myeloid leukemia in remission |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Histamine Histamine phosphate Aldesleukin Interleukin-2 Histamine Agonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Antineoplastic Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013