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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Myeloid
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014