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

This study has been terminated.
(Unable to meet accrual goals)
Sponsor:
Information provided by (Responsible Party):
Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT01289678
First received: February 2, 2011
Last updated: March 6, 2017
Last verified: March 2017
February 2, 2011
March 6, 2017
July 2006
August 31, 2016   (Final data collection date for primary outcome measure)
Event-free survival [ Time Frame: 10 years ]
Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
Same as current
Complete list of historical versions of study NCT01289678 on ClinicalTrials.gov Archive Site
Patient response [ Time Frame: 10 years ]

Response:

Morphologic Complete Remission (CR)

Same as current
Not Provided
Not Provided
 
Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Acute Myelogenous Leukemia
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
Experimental: interleukin-2
interleukin-2 therapy during lymphocyte recovery
Intervention: Drug: Interleukin-2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
August 31, 2016
August 31, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01289678
LJCC 06-05
Yes
Not Provided
Not Provided
Not Provided
Leo W. Jenkins Cancer Center
Leo W. Jenkins Cancer Center
Not Provided
Principal Investigator: Paul Walker, MD The Brody School of Medicine at East Carolina University
Leo W. Jenkins Cancer Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP