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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003991




Registration number
NCT00003991
Ethics application status
Date submitted
1/11/1999
Date registered
3/06/2004
Date last updated
6/11/2013

Titles & IDs
Public title
Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
Scientific 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)
Secondary ID [1] 0 0
MAXIM-MP-MA-0201
Secondary ID [2] 0 0
CDR0000067196
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - aldesleukin
Treatment: Drugs - histamine dihydrochloride

Other interventions: aldesleukin


Treatment: Drugs: histamine dihydrochloride
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [5] 0 0
NSW Breast Cancer Institute - Westmead
Recruitment hospital [6] 0 0
Wesley Clinic for Hematology/Oncology - Auchenflower
Recruitment hospital [7] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [9] 0 0
Mater Public Hospital - South Brisbane
Recruitment hospital [10] 0 0
Hanson Center for Cancer Research - Adelaide
Recruitment hospital [11] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [12] 0 0
Monash Medical Center - East Bentleigh
Recruitment hospital [13] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [14] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [16] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
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NSW 2310 - Newcastle
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2065 - St. Leonards
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2010 - Sydney
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2145 - Westmead
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
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4029 - Brisbane
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4102 - Brisbane
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
5006 - Adelaide
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5011 - Adelaide
Recruitment postcode(s) [12] 0 0
3165 - East Bentleigh
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8006 - East Melbourne
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
6000 - Perth
Recruitment postcode(s) [16] 0 0
6160 - Fremantle
Recruitment outside Australia
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Alabama
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Missouri
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Aalborg
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Tallinn
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Rostock
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Ramat Gan
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Auckland
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Christchurch
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New Zealand
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Hamilton
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Palmerston North
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Wellington
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Eskilstuna
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Kalmar
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Karlstad
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Linkoping
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Vasteras
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United Kingdom
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England

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Maxim Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003991
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbara Berryhill
Address 0 0
Maxim Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00003991