|Secondary Protocol No.
||MNPrtnrshpBiotech+Med Gen; Mayo IRB 12-004104
||MT2012-04 Decitabine and Vorinostat with CD3/CD19 Depleted Haploidentical Donor Natural Killer (NK) Cells for the Treatment of High Risk Myelodysplastic Syndromes (MDS)
||Evaluate the objective response rate (CR + PR+ Hematologic Improvement (HI)) after 2 courses of Decitabine and Vorinostat with haploidentical NK cells in high risk myelodysplastic syndrome (MDS).
||Patients will be treated with Decitabine, Vorinostat, Interleukin-2 activated donor natural killer cell infusion and Interleukin-2 over a 22 day cycle. A second cycle, 6-8 weeks after the start of cycle 1, will be offered if treatment was tolerated and no progression to AML.
||This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor NK cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion. Two courses of treatment will be given separated by 6 - 8 weeks.
||Patient must have a diagnosis of high risk MDS requiring treatment.
|Applicable Disease Sites
||Myelodysplastic syndromes (MDS)
IL-2 (INTERLEUKIN-2, ALDESLEUKIN,PROLEUKIN)
NK cell infusion
||Masonic Cancer Center
Mayo Clinic Cancer Center
||Must be between 18 and 75 years of age and have acceptable organ function. Must also have the ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to NK cell infusion. Women of childbearing potential must agree to use effective methods of contraception. Women who are pregnant or nursing are not eligible. Anyone with an uncontrolled bacterial or viral infection, inability to swallow capsules, or with active HIV are not eligible. A signed informed consent and HIPAA authorization are required.
||Cancer Information Line nurse
Phone: 612-624-2620 - 1-888-226-2376