View Clinical Trial (Medical Research Study)
Pharmacologic Upregulation of Cancer Testis Antigens Followed by Vaccine Therapy for Patients With Relapsed Acute Myelogenous Leukemia (AML) Following Allogeneic Stem Cell Transplantation
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Acute Myelogenous Leukemia |
| Purpose: |
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Patients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell
transplant cell receive decitabine to up regulate cancer antigen expression, followed by a
donor lymphocyte infusion and an autologous dendritic cell (DC). Vaccine Dendritic cells
are pulsed with overlapping peptides derived from MAGE-A1, MAGE-A3, and NY-ESO-1.
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| Study Summary: |
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For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived
from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.
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| Criteria: |
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Inclusion Criteria:
- Age 18 - 75 years
- Histologically or cytologically documented relapse of acute myeloid leukemia after a
stem cell transplant
- Must have a minimum of 10% donor cells by chimerism assays (RFLP or FISH) prior to
enrollment
- Patients must be at least 2 weeks from cessation of immunosuppression.
- Donors must be no more than two HLA antigen (HLA A, B, C, DR) mismatched with the
transplant recipient by high resolution molecular HLA typing.
- ECOG performance status 0-2, Lansky performance status >70 (see Appendix 1).
- Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days of enrollment.
- Male and female patients must agree to use a medically acceptable barrier and/or
chemical contraceptive method during the study and for a minimum of 3 months after
the last dose of chemotherapy on this study.
Exclusion Criteria:
- Active CNS leukemia. Prior CNS leukemia allowed provided current CSF cytology is
normal.
- Current concomitant chemotherapy, radiation therapy, or immunotherapy. Must be off
therapy for at least 2 weeks prior to enrollment with the following exceptions:
- Hydroxyurea: at least 72 hours
- Biologic agents (e.g., Imatinib, dasatinib, etc.): at least 7 days
- Hematopoietic growth factors (e.g., filgrastim, pegfilgrastim, etc.): at least 7 days
- Persistent clinically significant toxicity from prior anticancer therapy that is >
Grade 2 (NCI CTCAE v3.0).
- Bilirubin > 2 mg/dL, and SGOT/SGPT >2.5 x normal.
- Ejection fraction by echocardiogram < 50%
- Absolute neutrophil count < 500, platelet count < 25,000
- Creatinine clearance < 50ml/min as estimated by patient's serum creatinine, weight,
and age.
- Room air pulse oximetry < 94%.
- Bone marrow or stem cell transplant within 2 months prior to treatment on protocol
- Pregnant or lactating females are excluded.
- Other active systemic malignancy other than leukemia expected to require therapy
within 4 months.
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled
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| NCT ID: |
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NCT01483274 |
| Primary Contact: |
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Principal Investigator
Kenneth G Lucas, MD
Penn State Hershey Medical Center
Kenneth G Lucas, MD
Phone: 717-531-6012
Email: klucas@hmc.psu.edu
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| Backup Contact: |
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Email: creed@hmc.psu.edu
Cynthia A Reed
Phone: 717-531-5299
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| Location Contact: |
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Hershey, Pennsylvania 17033
United States
Kenneth G Lucas, MD
Phone: 717-531-6012
Email: klucas@hmc.psu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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