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

• Sponsor: Leo W. Jenkins Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01289678
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 122
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia	Drug: Interleukin-2	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Aug 31, 2016
• Actual Study Completion Date: Aug 31, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Leo W. Jenkins Cancer Center	Greenville	North Carolina	United States	27834

Sponsors and Collaborators

• Leo W. Jenkins Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leo W. Jenkins Cancer Center
• ClinicalTrials.gov Identifier: NCT01289678
• Other Study ID Numbers: LJCC 06-05
• First Posted: Feb 4, 2011
• Last Update Posted: Sep 12, 2019
• Last Verified: Mar 1, 2017

• Keywords provided by Leo W. Jenkins Cancer Center: acute myelogenous leukemia; interleukin-2
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Interleukin-2

Study Results

Participant Flow

Arm/Group Title	Interleukin-2
Arm/Group Description	interleukin-2 therapy during lymphocyte recovery 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
Period Title: Overall Study
STARTED	18
COMPLETED	12
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Interleukin-2
Arm/Group Description	interleukin-2 therapy during lymphocyte recovery 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
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 50%
>=65 years	6 50%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	57
Sex: Female, Male (Count of Participants)
Female	8 66.7%
Male	4 33.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interleukin-2
Arm/Group Description	interleukin-2 therapy during lymphocyte recovery 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
Measure Participants	12
Count of Participants [Participants]	5 41.7%

Adverse Events

Time Frame	3 years post-consolidation therapy
Arm/Group Title	Interleukin-2
Arm/Group Description	interleukin-2 therapy during lymphocyte recovery 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
All Cause Mortality
	Interleukin-2
	Affected / at Risk (%)	# Events
Total	7/12 (58.3%)
Serious Adverse Events
	Interleukin-2
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Interleukin-2
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.