The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is also being done to see how well the combination of these drugs works to fight myelodysplastic syndrome (MDS).
Fixed dose of lenalidomide at 10 mg/day, Days 1- 21 of 28 days of treatment cycle, and 4 dose escalations of GM.CD40L vaccine: 10 X 10\^6 GM.CDL cells per vaccination; 30 X 10\^6 GM.CDL cells per vaccination; 60 X 10\^6 GM.CDL cells per vaccination; 120 X 10\^6 GM.CDL cells per vaccination; Vaccination at 2-week intervals, on days 8 and 22, for a total of four 28-day cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Patients will take 10 mg capsules of lenalidomide per day for 21 days followed by 7 days of rest. This 28 day period is considered 1 cycle. Patients will receive 4 treatment cycles with 28 days in each cycle.
In addition to lenalidomide, during each 28 day cycle patients will also receive GM.CD40L bystander vaccination injections in 2-week intervals on days 8 and 22 for a total of 8 immunizations during the 4 cycle treatment period.
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Maximum Tolerated Dose (MTD)
Determination of MTD of GM.CD40L bystander vaccine with lenalidomide in high-risk MDS patients.
Time frame: 24 months
Number of Participants with Toxicities
Determination of toxicities associated with combination of GM.CD40L bystander vaccine with lenalidomide in high-risk MDS patients.
Time frame: 24 months
Number of Participants with Augmentation of Specific T Cell Immunological Functions
Augmentation of specific T cell immunological functions; T cell proliferation and Interferon-γ production, delayed type hypersensitivity (DTH) sensitivity by lenalidomide.
Time frame: 24 months
Number of Participants with Reduction of Bone Marrow Myeloblast
Reduction of bone marrow myeloblast from baseline to post treatment with lenalidomide and GM.CD40L bystander vaccine.
Time frame: 24 months
Number of Participants with Improvement of Hemoglobin and/or red blood cell (RBC) Transfusion Independence
Improvement of hemoglobin and/or RBC transfusion independence after combined immunotherapy treatment.
Time frame: 24 months
Number of Participants with Resolution of Karyotypic Changes
Resolution of karyotypic changes after combined treatment.
Time frame: 24 months
Number of Participants with Augmentation of Other T Cell Parameters
Augmentation of other T cell parameters after the combined treatment.
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Time frame: 24 months
Duration of Response
Determination of response duration evaluated by Wilms Tumor 1 (WT1) expression and clinical outcomes. Clinical response will be assessed using International Working Group (IWG) criteria.
Time frame: 24 months