This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex vivo-generated allogeneic natural killer (NK) cells with or without preceding non-myeloablative conditioning chemotherapy.
This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex vivo-generated allogeneic natural killer (NK) cells with or without preceding non-myeloablative conditioning chemotherapy. This study is a phase I safety and feasibility study in a series of 12 patients who are suffering from recurrent ovarian, fallopian tube or primary peritoneal cancer. Prior to NK cell infusion, a laparoscopy is performed to place a catheter in the peritoneal cavity. The first cohort of three patients will receive an intraperitoneal infusion of allogeneic UCB-NK cells generated ex vivo from CD34+ hematopoietic progenitor cells obtained from an allogeneic UCB unit without a preparative regimen. In the second group of three patients the same UCB-NK cell dosage will be given with a preparative regimen of four days non-myeloablative immunosuppressive conditioning regimen with cyclophosphamide and fludarabine (CyFlu). If no severe toxicity is seen in these 6 patients, an extension cohort of 6 patients will be included to answer the secondary objective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Intraperitoneal allogeneic UCB-NK cells infusion
Cyclofosfamide/fludarabine treatment
Radboudumc
Nijmegen, Netherlands
Incidence of treatment emergent adverse events
Incidence of treatment emergent adverse events (following CTCAE criteria)
Time frame: 6 months
in vivo lifespan of the infused UCB-NK cells
determination of NK cell percentage in blood and peritoneal fluid
Time frame: 28 days
in vivo expansion of the infused UCB-NK cells
determination of NK cell percentage in peritoneal fluid and blood
Time frame: 28 days
Measurement of in vitro cytolytic activity of infused NK cells
in CFSE base killing assays a percentage of dead cells (K562 cells) will be measured.
Time frame: 28 days
the effect of NK cell infusion on measurable disease
CA-125 testing in blood (in E/mL)
Time frame: 6 months
the effect of NK cell infusion on measurable disease
CT-scan (measurement of visible leasions in cm)
Time frame: 6 months
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