Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT02118285|
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Carcinoma Primary Peritoneal Carcinoma||Drug: Fludarabine Drug: Cyclophosphamide Biological: NK cells Biological: IL-2 Drug: INCB024360||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 28, 2014|
|Primary Completion Date :||November 12, 2015|
|Study Completion Date :||November 12, 2015|
Haploidentical donor NK cells and IL-2 are infused intraperitoneally (IP) after a non-myeloablative preparative regimen of cyclophosphamide and fludarabine. INCB024360, at the assigned dose, begins 2 days before the NK cell infusion and continues twice daily for 90 days.
Fludarabine 25 mg/m^2 IV on days -6 through -2 from NK cell infusion
Other Name: FludaraDrug: Cyclophosphamide
Cyclophosphamide 30 mg/kg IV on days -5 and -4 from NK cell infusion
Other Names:Biological: NK cells
CD3-/CD19- selected NK cells administered by intraperitoneal (IP) infusion on day 0
Other Name: Natural Killer CellsBiological: IL-2
IL-2 at 6 million units/dose IP 3 times a week x 6 doses with the 1st dose given immediately after the NK cell infusion
Other Name: Interleukin 2Drug: INCB024360
INCB024360 at assigned dose by mouth twice a day begin day -2 and continue for 90 days (+/- 3 days)
- Maximum tolerated dose of INCB024360 [ Time Frame: 90 days ]To determine the maximum tolerated dose (MTD) of INCB024360 when administered with intraperitoneal haploidentical donor NK cells/IL-2 after a nonmyeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer
- Initial tumor response [ Time Frame: 90 days ]The proportion of patients with initial tumor response (CR or PR)
- Duration of tumor response [ Time Frame: 1 year ]Duration of tumor response
- Progression-free survival [ Time Frame: 5 years ]Average time to progression.
- Overall survival [ Time Frame: 5 years ]Average length of survival after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118285
|United States, Minnesota|
|University of Minnesota Masonic Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Melissa Geller, MD||University of Minnesota - Clinical and Translational Science Institute|