Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission
Condition: 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)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

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
    

Detailed description: 
      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.
    

Intervention name(s): basiliximab; WT1 126-134 peptide vaccine; Montanide ISA 51 VG; poly ICLC; laboratory biomarker analysis
Intervention type(s): Biological; Biological; Drug; Drug; Other
Intervention description(s): Given IV; Given SC; Given SC; Given SC; Correlative studies
Other intervention name(s): SDZ-CHI-621; Simulect; Hiltonol; poly I:poly C with poly-1-lysine stabilizer; Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose; stabilized polyriboinosinic/polyribocytidylic acid
Intervention MeSH terms: Poly I-C; Carboxymethylcellulose Sodium; Monatide (IMS 3015); Poly ICLC; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment