Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
NCT ID: NCT01289678
Last Updated: 2019-09-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
18 participants
INTERVENTIONAL
2006-07-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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interleukin-2
interleukin-2 therapy during lymphocyte recovery
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Active thrombocytopenic bleeding
* Cardiac ejection fraction below 45%
* Pregnancy and/or lactation
18 Years
ALL
No
Sponsors
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Leo W. Jenkins Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Paul Walker, MD
Role: PRINCIPAL_INVESTIGATOR
The Brody School of Medicine at East Carolina University
Locations
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Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States
Countries
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Other Identifiers
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LJCC 06-05
Identifier Type: -
Identifier Source: org_study_id
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