Overview

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

Status:
Terminated
Trial end date:
2016-08-31
Target enrollment:
0
Participant gender:
All
Summary
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Leo W. Jenkins Cancer Center
Treatments:
Famotidine
Interleukin-2
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