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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)

Phase 3
18 Years
Open (Enrolling)

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Trial Information

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)

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.

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.)

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Barbara Berryhill

Investigator Role:

Study Chair

Investigator Affiliation:

Maxim Pharmaceuticals


United States: Federal Government

Study ID:




Start Date:

July 1998

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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