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Pharmacologic Upregulation of Cancer Testis Antigens Followed by Vaccine Therapy for Patients With Relapsed Acute Myelogenous Leukemia (AML) Following Allogeneic Stem Cell Transplantation


Phase 1
18 Years
75 Years
Not Enrolling
Both
Acute Myelogenous Leukemia

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Trial Information

Pharmacologic Upregulation of Cancer Testis Antigens Followed by Vaccine Therapy for Patients With Relapsed Acute Myelogenous Leukemia (AML) Following Allogeneic Stem Cell Transplantation


For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived
from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerance of study treatment

Outcome Description:

Tolerance to DAC, at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Kenneth G Lucas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State Hershey Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

36361

NCT ID:

NCT01483274

Start Date:

June 2012

Completion Date:

August 2012

Related Keywords:

  • Acute Myelogenous Leukemia
  • AML
  • vaccine
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Penn State Hershey Medical Center Hershey, Pennsylvania  17033