Breast Cancer Clinical Trial
Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
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.
Full 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.
Eligibility Criteria
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.)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 115 Locations for this study
Birmingham Alabama, 35294, United States
Tucson Arizona, 85724, United States
La Jolla California, 92037, United States
Los Angeles California, 90048, United States
San Diego California, 92120, United States
San Diego California, 92121, United States
San Francisco California, 94115, United States
Boynton Beach Florida, 33473, United States
Jacksonville Florida, 32209, United States
Atlanta Georgia, 30322, United States
Kansas City Kansas, 66160, United States
Westwood Kansas, 66205, United States
Scarborough Maine, 04074, United States
Detroit Michigan, 48202, United States
Southfield Michigan, 48075, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89106, United States
Reno Nevada, 89502, United States
Albuquerque New Mexico, 87131, United States
Bronx New York, 10466, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Valhalla New York, 10595, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73190, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15224, United States
Memphis Tennessee, 38117, United States
Memphis Tennessee, 38119, United States
Dallas Texas, 75246, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Liverpool New South Wales, 2170, Australia
Newcastle New South Wales, NSW 2, Australia
St. Leonards New South Wales, 2065, Australia
Sydney New South Wales, 2010, Australia
Westmead New South Wales, 2145, Australia
Auchenflower Queensland, 4066, Australia
Brisbane Queensland, 4029, Australia
Brisbane Queensland, 4102, Australia
South Brisbane Queensland, 4101, Australia
Adelaide South Australia, 5006, Australia
Adelaide South Australia, 5011, Australia
East Bentleigh Victoria, 3165, Australia
East Melbourne Victoria, 8006, Australia
Parkville Victoria, 3050, Australia
Perth Western Australia, 6000, Australia
Fremantle , 6160, Australia
Vancouver British Columbia, V5Z 1, Canada
Halifax Nova Scotia, B3H 2, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 8, Canada
Montreal Quebec, H3H 1, Canada
Montreal Quebec, H4J 1, Canada
Quebec City Quebec, G1R 2, Canada
Saskatoon Saskatchewan, S7N 0, Canada
Aalborg , 9100, Denmark
Odense , DK-50, Denmark
Tallinn , 10138, Estonia
Tartu , EE-24, Estonia
Helsinki , FIN-0, Finland
Kuopio , FIN-7, Finland
Tampere , 33521, Finland
Turku , FIN-2, Finland
Angers , 49033, France
Besancon , 25030, France
Clichy , 92118, France
Le Chesnay , 78157, France
Lille , 59037, France
Lyon , 69437, France
Nantes , 44093, France
Rouen , 76038, France
Augsburg , DOH-8, Germany
Berlin , D-101, Germany
Bremen , D-282, Germany
Dresden , D-013, Germany
Essen , D-451, Germany
Frankfurt , D-605, Germany
Halle Saale , DOH-0, Germany
Hamburg , D-202, Germany
Hannover , D-306, Germany
Heidelberg , D-691, Germany
Osnabruck , DOH-4, Germany
Rostock , D-180, Germany
Saarbrucken , D-661, Germany
Tuebingen , D-720, Germany
Ulm , D-890, Germany
Wurzburg , 97070, Germany
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petach-Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Rehovot , 76100, Israel
Tel-Aviv , 62995, Israel
Auckland , 3, New Zealand
Christchurch , , New Zealand
Hamilton , 2020, New Zealand
Palmerston North , , New Zealand
Wellington , 2, New Zealand
Eskilstuna , 63188, Sweden
Gothenburg (Goteborg) , S-413, Sweden
Kalmar , 39185, Sweden
Karlstad , 65185, Sweden
Linkoping , S-581, Sweden
Lund , SE-22, Sweden
Malmo , S-205, Sweden
Orebro , 70185, Sweden
Skovde , 54185, Sweden
Stockholm , S-141, Sweden
Stockholm , S-171, Sweden
Sundsvall , 85283, Sweden
Uddevalla , 45189, Sweden
Umea , S-901, Sweden
Uppsala , S-751, Sweden
Vasteras , 72189, Sweden
Birmingham England, B9 5S, United Kingdom
Leeds England, LS1 3, United Kingdom
Manchester England, M13 9, United Kingdom
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.