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

NCT01289678 — Phase 2, Terminated, 18 participants, Leo W. Jenkins Cancer Center

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

Registry	NCT01289678
Status	Terminated - Unable to meet accrual goals
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	18 (Actual)
Sponsor	Leo W. Jenkins Cancer Center (Other)
Conditions	Acute Myelogenous Leukemia
Interventions	Interleukin-2 (Drug)
Dates	start 2006-07-01, primary completion 2016-08-31, completion 2016-08-31, first posted 2011-02-04, last updated 2019-09-12
Locations	1 site in United States

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
interleukin-2	Experimental	Drug: Interleukin-2	interleukin-2 therapy during lymphocyte recovery

Interleukin-2 (Drug), also known as pulse: 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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	Interleukin-2
Started	18
Completed	12
Not completed	6

Outcome results

Event-free Survival (Primary), Count of participants, Participants: Interleukin-2 5

Adverse events

Time frame: 3 years post-consolidation therapy

Arm	Deaths	Serious adverse events	Other adverse events
Interleukin-2	7/12 (58.3%)	0/12 (0.0%)	0/12 (0.0%)

+Locations (1)

Facility	City	Country	Status
Leo W. Jenkins Cancer Center	Greenville, North Carolina	United States

+Investigators

Paul Walker, MD, Principal investigator, The Brody School of Medicine at East Carolina University