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Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia

This study has been terminated.
(Unable to meet accrual goals)
Information provided by (Responsible Party):
Leo W. Jenkins Cancer Center Identifier:
First received: February 2, 2011
Last updated: March 6, 2017
Last verified: March 2017
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

Condition Intervention Phase
Acute Myelogenous Leukemia
Drug: Interleukin-2
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia

Resource links provided by NLM:

Further study details as provided by Leo W. Jenkins Cancer Center:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 10 years ]
    Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death

Secondary Outcome Measures:
  • Patient response [ Time Frame: 10 years ]


    Morphologic Complete Remission (CR)

Enrollment: 13
Study Start Date: July 2006
Study Completion Date: August 31, 2016
Primary Completion Date: August 31, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: interleukin-2
interleukin-2 therapy during lymphocyte recovery
Drug: Interleukin-2
Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment
  • Total WBC recovery of 500 mm3 prior to IL-2 treatment
  • Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment
  • Active infection controlled prior to starting IL-2 treatment
  • Stable systolic blood pressure > 90mm Hg prior to starting IL-2 treatment
  • O2 saturation >90% prior to starting treatment
  • Stable cardiopulmonary status prior to starting IL-2 treatment
  • Serum creatinine < or equal to 2.0 mg/dl
  • Total bilirubin and AST <3x upper limits normal

Exclusion Criteria:

  • Acute Promyelocytic Leukemia
  • Active thrombocytopenic bleeding
  • Cardiac ejection fraction below 45%
  • Pregnancy and/or lactation
  Contacts and Locations
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Please refer to this study by its identifier: NCT01289678

United States, North Carolina
Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
Principal Investigator: Paul Walker, MD The Brody School of Medicine at East Carolina University
  More Information

Responsible Party: Leo W. Jenkins Cancer Center Identifier: NCT01289678     History of Changes
Other Study ID Numbers: LJCC 06-05
Study First Received: February 2, 2011
Last Updated: March 6, 2017

Keywords provided by Leo W. Jenkins Cancer Center:
acute myelogenous leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 26, 2017