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

NCT ID: NCT01289678

Last Updated: 2019-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2016-08-31

Brief Summary

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Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

Detailed Description

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Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered

Conditions

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Acute Myelogenous Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interleukin-2

interleukin-2 therapy during lymphocyte recovery

Group Type EXPERIMENTAL

Interleukin-2

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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pulse

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leo W. Jenkins Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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LJCC 06-05

Identifier Type: -

Identifier Source: org_study_id

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