Ignite Creation Date:
2024-05-06 @ 1:35 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01842139
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2012-07-03
Brief Title:
Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Randomized Phase I Study Combining Suppression of T Regulatory Cells With WT1 Vaccine Therapy for AML Patients in Complete Remission
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CD25 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
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 CD25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-03588 | REGISTRY | CTRP Clinical Trial Reporting Program | None |