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Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

NCT02118285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-12-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Fludarabine

Fludarabine 25 mg/m\^2 IV on days -6 through -2 from NK cell infusion

DRUG

Cyclophosphamide

Cyclophosphamide 30 mg/kg IV on days -5 and -4 from NK cell infusion

BIOLOGICAL

NK cells

CD3-/CD19- selected NK cells administered by intraperitoneal (IP) infusion on day 0

BIOLOGICAL

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

DRUG

INCB024360

INCB024360 at assigned dose by mouth twice a day begin day -2 and continue for 90 days (+/- 3 days)

Sponsors & Collaborators

  • Incyte Corporation

    collaborator INDUSTRY

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Melissa Geller, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-28
Primary Completion
2015-11-12
Completion
2015-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02118285 on ClinicalTrials.gov