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

This study is currently recruiting participants.
Verified August 2013 by Leo W. Jenkins Cancer Center
Sponsor:
Information provided by (Responsible Party):
Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT01289678
First received: February 2, 2011
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    Response:

    Morphologic Complete Remission (CR)



Estimated Enrollment: 14
Study Start Date: July 2006
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289678

Locations
United States, North Carolina
Leo W. Jenkins Cancer Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Paul Walker, MD    252-744-5386    Walkerp@ecu.edu   
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
Investigators
Principal Investigator: Paul Walker, MD The Brody School of Medicine at East Carolina University
  More Information

No publications provided

Responsible Party: Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier: NCT01289678     History of Changes
Other Study ID Numbers: LJCC 06-05
Study First Received: February 2, 2011
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 22, 2014