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Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission

NCT01842139 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-03-09

No results posted yet for this study

Summary

This randomized phase I trial studies the side effects and best way to give vaccine therapy together with basiliximab in treating patients with acute myeloid leukemia (AML) in complete remission. Vaccines made from the WT1 peptide may help the body build an effective immune response to kill cancer cells. Montanide ISA 51 VG and poly-ICLC may enhance this response. Monoclonal antibodies, such as basiliximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether WT1 126-134 peptide vaccine with Montanide ISA 51 VG is more effective than with poly-ICLC when given together with basiliximab in treating AML

Conditions

  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)

Interventions

BIOLOGICAL

basiliximab

Given IV

BIOLOGICAL

WT1 126-134 peptide vaccine

Given SC

DRUG

Montanide ISA 51 VG

Given SC

DRUG

poly ICLC

Given SC

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Chicago

    lead OTHER

Principal Investigators

  • Hongtao Liu · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-05
Primary Completion
2015-02-02
Completion
2018-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01842139 on ClinicalTrials.gov