Randomized Phase I Study Combining Suppression of T Regulatory Cells With WT1 Vaccine Therapy for AML Patients in Complete Remission
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of peptide specific immunologic response between regimens
Evaluated by flow cytometry and using IFN-gamma ELISPOT as the primary measures. Compared using a two-sample t test.
Over 9 months
University of Chicago
United States: Institutional Review Board
|University of Chicago||Chicago, Illinois 60637|