Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Conditions
Acute Myelogenous Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
acute myelogenous leukemia, interleukin-2
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Interleukin-2
Type: Drug
Overall Status
Recruiting
Summary
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States
Status: Recruiting
Contact: Paul Walker, MD - 252-744-5386 - Walkerp@ecu.edu
Start Date
July 2006
Completion Date
June 2020
Sponsors
Leo W. Jenkins Cancer Center
Source
Leo W. Jenkins Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page