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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03588 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (vaccine with Montanide) | Experimental | Patients receive WT1 126-134 peptide vaccine emulsified in Montanide ISA 51 VG SC on day 0 and then once every 2 weeks. |
|
| Arm B (vaccine with poly-ICLC) | Experimental | Patients receive WT1 126-134 peptide vaccine in poly-ICLC SC on day 0 and then once every 2 weeks. |
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| Arm C (vaccine therapy, monoclonal antibody) | Experimental | Patients assigned to Arm C receive basiliximab 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| basiliximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Comparison of regulatory T cells (Treg) number changes between regimens | Evaluated by flow cytometry and using interferon (IFN)-gamma Enzyme-linked immunosorbent spot (ELISPOT) as the primary measures. Compared using a two-sample test. The Treg cell counts and percentage by flow cytometry, the FoxP3 expression by qRT-PCR, and the peptide specific CD8+cell level by ELISPOT will be measured continuously prior to basiliximab and WT1 126-134 peptide vaccine and after basiliximab and/or WT! 126-134 peptide vaccine. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Molecular response in terms of WT1 expression | Every 12 weeks for 1 year after stopping treatment | |
| Relapse-free survival | Every 12 weeks for 1 year after stopping treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongtao Liu | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637-1470 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29344432 | Derived | Liu H, Zha Y, Choudhury N, Malnassy G, Fulton N, Green M, Park JH, Nakamura Y, Larson RA, Salazar AM, Odenike O, Gajewski TF, Stock W. WT1 peptide vaccine in Montanide in contrast to poly ICLC, is able to induce WT1-specific immune response with TCR clonal enrichment in myeloid leukemia. Exp Hematol Oncol. 2018 Jan 11;7:1. doi: 10.1186/s40164-018-0093-x. eCollection 2018. |
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| WT1 126-134 peptide vaccine | Biological | Given SC |
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| Montanide ISA 51 VG | Drug | Given SC |
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| poly ICLC | Drug | Given SC |
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| laboratory biomarker analysis | Other | Correlative studies |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000077552 | Basiliximab |
| C477385 | montanide ISA 51 |
| C019531 | poly ICLC |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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