Finding studies
Finding studies
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Lead
University of Chicago
With
PRIMARY OBJECTIVES: I. To examine the immunogenicity of WT1 peptide (WT1 126-134 peptide vaccine) emulsified in Montanide (Montanide ISA 51 VG) in elderly patients with AML. II. To determine whether toll-like receptor 3 (TLR3) agonist (poly-L-lysine and carboxymethyl cellulose \[poly ICLC\]) could be a potent immunologic adjuvant, and increases the frequencies of WT1-specific T cells following vaccination. III. To determine whether depletion of regulatory T cells occurs upon administration of the anti-cluster of differentiation (CD)25 monoclonal antibody Basiliximab, and whether this is associated with increased frequencies of WT1-specific T cells following vaccination. IV. To assess whether WT1 vaccination +/- TLR3 agonist (poly ICLC) combined with Basiliximab results in decreased levels of WT1 transcripts in peripheral blood cells compared to WT1 vaccination +/- TLR3 as measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR). SECONDARY OBJECTIVES: I. To examine the safety and gain preliminary information on efficacy of WT1 peptide vaccination +/- TLR3 agonist (poly ICLC) combined with Basiliximab. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive WT1 126-134 peptide vaccine emulsified in Montanide ISA 51 VG subcutaneously (SC) on day 0 and then once every 2 weeks. ARM B: Patients receive WT1 126-134 peptide vaccine emulsified in poly-ICLC SC on day 0 and then once every 2 weeks. ARM C: Patients assigned to Arm C receive basiliximab intravenously (IV) over 30 minutes on day -7 and WT1 126-134 peptide vaccine as in Arm A or Arm B, whichever had a superior cellular immune response. In all arms, treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients may then receive 6 additional monthly vaccinations. After completion of study treatment, patients are followed up for up to 2 years.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
