Decitabine and Vaccine Therapy for Patients With Relapsed AML Following Allogeneic Stem Cell Transplantation
This study has been withdrawn prior to enrollment.
(PI transferred to University of Louisville)
Sponsor:
University of Louisville
Collaborator:
Study was initiated at Penn State University, closed upon transfer of PI, and will be reopened at University of Louisville.
Information provided by (Responsible Party):
Kenneth Lucas, Penn State University
ClinicalTrials.gov Identifier:
NCT01483274
First received: November 3, 2011
Last updated: June 10, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia |
Biological: Vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacologic Upregulation of Cancer Testis Antigens Followed by Vaccine Therapy for Patients With Relapsed Acute Myelogenous Leukemia (AML) Following Allogeneic Stem Cell Transplantation |
Resource links provided by NLM:
Further study details as provided by University of Louisville:
Primary Outcome Measures:
- Tolerance of study treatment [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Tolerance to DAC, at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles
Secondary Outcome Measures:
- Disease Responce [ Time Frame: 4 years ] [ Designated as safety issue: No ]Assessment of Bone Marrow asperation to check for complete or partial remission, stable disease, and desease prgression by bone marrow draws at week 6 and week 12.
- Immune Responce [ Time Frame: 4 years ] [ Designated as safety issue: No ]Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassay
| Enrollment: | 0 |
| Study Start Date: | June 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Safety
Decitabine and donor lymphocyte infused dendritic cell (DC).
|
Biological: Vaccine
Decitabine followed by doner lymphocyte infusing and Dendritic cells pulsed with MAGE-A1, MAGE-A3, and NEY-ESO-1 vaccine
Other Names:
|
|
Active Comparator: Vaccine
Decitabine and Dendritic cell (DC) pulsed with MAGE-A1, MAGE-A3, NY-ESO-1 Peptides
|
Biological: Vaccine
Decitabine followed by doner lymphocyte infusing and Dendritic cells pulsed with MAGE-A1, MAGE-A3, and NEY-ESO-1 vaccine
Other Names:
|
Detailed Description:
For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483274
Locations
| United States, Pennsylvania | |
| Penn State Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
Sponsors and Collaborators
University of Louisville
Study was initiated at Penn State University, closed upon transfer of PI, and will be reopened at University of Louisville.
Investigators
| Principal Investigator: | Kenneth G Lucas, MD | Penn State Hershey Medical Center |
More Information
No publications provided
| Responsible Party: | Kenneth Lucas, Professor of Pediatrics, Penn State University |
| ClinicalTrials.gov Identifier: | NCT01483274 History of Changes |
| Other Study ID Numbers: | 36361 |
| Study First Received: | November 3, 2011 |
| Last Updated: | June 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Louisville:
|
AML vaccine |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Decitabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013