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

NCT01289678 | Terminated Phase 2 Results DMC

• 1 other identifier: LJCC 06-05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myelogenous Leukemia

Keywords

acute myelogenous leukemia; interleukin-2

Outcome Measures

Primary Outcomes (1)

• Event-free Survival

  Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death

  3 years

Study Arms (1)

interleukin-2

EXPERIMENTAL

interleukin-2 therapy during lymphocyte recovery

Drug: Interleukin-2

Interventions

Interleukin-2 DRUG

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

Also known as: pulse

interleukin-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute Promyelocytic Leukemia
• Active thrombocytopenic bleeding
• Cardiac ejection fraction below 45%
• Pregnancy and/or lactation

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead

Study Sites (1)

Leo W. Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Interleukin-2; Pulse

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Paul R. Walker, MD
• Organization: Brody School of Medicine

walkerp@ecu.edu

2527441888

Study Officials

• Paul Walker, MD

  The Brody School of Medicine at East Carolina University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 4, 2011
• Study Start: July 1, 2006
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2017-03

Locations

US (1)