Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
Randomized Phase I Study Combining Suppression of T Regulatory Cells With WT1 Vaccine Therapy for AML Patients in Complete Remission
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01564277 -
Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
Completed |
NCT01141725 -
Bendamustine Hydrochloride and Idarubicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1/Phase 2 | |
Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
Completed |
NCT00742625 -
Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
Terminated |
NCT00387426 -
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|
Phase 2 | |
Active, not recruiting |
NCT01056614 -
Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies
|
Phase 2 | |
Completed |
NCT00093418 -
S0432 Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
|
Phase 2 | |
Completed |
NCT00096122 -
Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Completed |
NCT00070551 -
GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Terminated |
NCT00052598 -
Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Completed |
NCT00052520 -
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
|
Phase 1/Phase 2 | |
Terminated |
NCT00049582 -
Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT01798901 -
AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia
|
Phase 1 | |
Terminated |
NCT01876953 -
Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Completed |
NCT01555268 -
Trebananib With or Without Low-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
Completed |
NCT01519596 -
Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
|
N/A | |
Completed |
NCT01253447 -
AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 2 |