Title
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
Phase
Phase 2Lead Sponsor
Leo W. Jenkins Cancer CenterStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Acute Myelogenous LeukemiaIntervention/Treatment
aldesleukin ...Study Participants
18Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.
Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered
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
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
| Event Type | Organ System | Event Term |
|---|
Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
