Ovarian Cancer Clinical Trial
Official title:
Indoleamine-2,3-dioxygenase (IDO) Inhibition With INCB024360 and Intraperitoneal Delivery of Allogeneic Natural Killer Cells for Women With Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
This is a single center phase I trial designed to determine the maximum tolerated dose (MTD) of the oral IDO inhibitor INCB024360 when administered as part of a larger regimen of intraperitoneal (IP) delivery of haploidentical donor NK cells and IL-2 after a non-myeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen for the treatment of recurrent ovarian, fallopian tube, and primary peritoneal cancer.
Haploidentical donor NK cells and the 1st dose of IL-2 are infused intraperitoneally (IP)
after a non-myeloablative preparative regimen of cyclophosphamide and fludarabine. IP IL-2
continues three times a week for 5 additional doses. INCB024360, at the assigned dose, begins
2 days before the NK cell infusion (on day -2) and continues twice daily for 90 days.
Follow-up for disease response and survival is for 1 year from the NK cell infusion with the
possibility of re-treatment for patients who experience at least a clinical benefit for a
minimum of 6 months prior to disease progression.
The MTD of INCB024360 will be determined using the continual reassessment method (CRM). The
1st 2 patients will be enrolled at dose level 1 (50 mg bid) of INCB024360. Each new cohort of
2 patients will be sequentially assigned to most appropriate dose by the study statistician
based on the updated toxicity profile. Up to 4 dose levels of INCB024360 will be tested (50,
100, 200, and 300 mg bid) with a dose level -1 (25 mg bid) used in the event that 50 mg bid
proves to be too toxic. The MTD will be identified when the total sample size of 20 patients
is exhausted.
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