Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Leo W. Jenkins Cancer Center
Information provided by (Responsible Party):
Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT01289678
First received: February 2, 2011
Last updated: January 13, 2012
Last verified: January 2012
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Purpose
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.
Condition | Intervention | Phase |
---|---|---|
Acute Myelogenous Leukemia |
Drug: Interleukin-2 |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia |
Resource links provided by NLM:
Further study details as provided by Leo W. Jenkins Cancer Center:
Primary Outcome Measures:
- Event-free survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
Secondary Outcome Measures:
- Patient response [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Response:
Morphologic Complete Remission (CR)
Estimated Enrollment: | 14 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289678
Locations
United States, North Carolina | |
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 |
More Information
No publications provided
Keywords provided by Leo W. Jenkins Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2012
No publications provided
Responsible Party: | Leo W. Jenkins Cancer Center |
ClinicalTrials.gov Identifier: | NCT01289678 History of Changes |
Other Study ID Numbers: | LJCC 06-05 |
Study First Received: | February 2, 2011 |
Last Updated: | January 13, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Leo W. Jenkins Cancer Center:
acute myelogenous leukemia interleukin-2 |
Additional relevant MeSH terms:
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Famotidine Interleukin-2 Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Histamine H2 Antagonists |
Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on September 30, 2012