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

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ClinicalTrials.gov Identifier: NCT01289678
Recruitment Status : Terminated (Unable to meet accrual goals)
First Posted : February 4, 2011
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Leo W. Jenkins Cancer Center

Brief Summary:
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: Interleukin-2 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Study Start Date : July 2006
Primary Completion Date : August 31, 2016
Study Completion Date : August 31, 2016


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Patient response [ Time Frame: 10 years ]

    Response:

    Morphologic Complete Remission (CR)




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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289678


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

Responsible Party: Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier: NCT01289678     History of Changes
Other Study ID Numbers: LJCC 06-05
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017

Keywords provided by Leo W. Jenkins Cancer Center:
acute myelogenous leukemia
interleukin-2

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Interleukin-2
Famotidine
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action