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

August 20, 2019 updated by: Leo W. Jenkins Cancer Center

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Leo W. Jenkins Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other Names:
  • pulse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival
Time Frame: 3 years
Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leo W. Jenkins Cancer Center

Investigators

  • Principal Investigator: Paul Walker, MD, The Brody School of Medicine at East Carolina University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

February 2, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 4, 2011

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LJCC 06-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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