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

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Brief Title

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

Official Title

Randomized Phase I Study Combining Suppression of T Regulatory Cells With WT1 Vaccine Therapy for AML Patients in Complete Remission

Brief 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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Comparison of peptide specific immunologic response between regimens

Secondary Outcome

 Molecular response in terms of WT1 expression

Condition

Adult Acute Myeloid Leukemia in Remission

Intervention

basiliximab

Study Arms / Comparison Groups

 Arm A (vaccine with Montanide)
Description:  Patients receive WT1 126-134 peptide vaccine emulsified in Montanide ISA 51 VG SC on day 0 and then once every 2 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

7

Start Date

December 5, 2011

Completion Date

March 2018

Primary Completion Date

February 2, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with Hematological malignancies, including AML, MDS, CML in blast phase and
             other conditions at the investigator's discretion.

          -  Bone marrow biopsy-confirmed CR or CRi, more than CR1 is allowed, such as CR2 or CR3.
             The enrollee is deemed not a candidate for stem cell transplant due to advanced age or
             co-morbidities; or the enrollee does not have donor available; or enrollee refuses
             stem cell transplant due to personal belief; or stem cell transplant is not current
             standard of care. Patients who are post stem cell transplant in CR or CRi are allowed
             if they are off immunosuppression,and not treated with systematic steroid for GVHD

          -  Karnofsky performance status index > or = 80%

          -  Written informed consent

          -  Absolute neutrophil count > or = 500/μl

          -  Platelet count >= 20,000/μl with transfusion

          -  Creatinine = or < 2 x upper limit of normal (ULN)

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate
             transaminase (SGPT) = or < 5 x ULN

          -  Bilirubin = or < 3 x ULN

          -  Human leukocyte antigens (HLA) typing: patient must express HLA-A2

          -  Age > 18 years and < 85 years

          -  Electrocardiogram (EKG) without evidence of arrhythmia or changes that indicate acute
             ischemia

          -  Pulse oximetry showing oxygen saturation of at least 90% on room air

          -  No irreversible coagulopathy, international normalized ratio (INR) =< 2

          -  No sign of tumor lysis syndrome, uric acid needs to be in normal range prior to
             treatment

          -  Not in diabetic ketoacidosis (DKA), sickle cell crisis, and not having severe
             peripheral vascular disease on active anti-coagulation treatment

        Exclusion Criteria:

          -  Pregnant or nursing women; women who still have child-bearing potential must be tested
             for urinary or serum beta human chorionic gonadotropin (βHCG)

          -  Biological or chemotherapy in the 4 weeks prior to the start of dosing

          -  Patients with intrinsic immunosuppression, including seropositivity for human
             immunodeficiency virus (HIV) antibody; patients should be tested for HIV

          -  Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis
             C; patients should be tested for hepatitis B surface antigen and hepatitis C antibody;
             patients who are hepatitis C antibody (Ab) positive can be eligible if they are PCR
             negative

          -  Active or history of confirmed autoimmune disease

          -  Concurrent systemic corticosteroids (except physiologic replacement doses) or other
             immunosuppressive drugs (eg. cyclosporin A)

          -  Active or history of autoimmune disease including but not limited to rheumatoid
             arthritis (rheumatoid factor [RF]-positive with current or recent flare), inflammatory
             bowel disease, systemic lupus erythematosus (clinical evidence with antinuclear
             antibody [ANA] 1:80 or greater), ankylosing spondylitis, scleroderma, multiple
             sclerosis, autoimmune hemolytic anemia, and immune thrombocytopenic purpura;
             seropositivity alone will not be considered positive

          -  Psychiatric illness that may make compliance to the clinical protocol unmanageable or
             may compromise the ability of the patient to give informed consent; patients with
             clinical evidence of dementia should have a competent designee participate in decision
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Hongtao Liu, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01842139

Organization ID

11-0545

Secondary IDs

NCI-2011-03588

Responsible Party

Sponsor

Study Sponsor

University of Chicago

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Hongtao Liu, Principal Investigator, University of Chicago


Verification Date

March 2018