Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int
Status: | Recruiting |
---|---|
Conditions: | Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/21/2019 |
Start Date: | October 19, 2017 |
End Date: | April 1, 2020 |
Contact: | Kimberly Brunsvold |
Email: | kwren@umn.edu |
Phone: | 612-626-2315 |
Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Interleukin-2 in Women With Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
This is a Phase I trial to determine the maximum tolerated dose/maximum feasible dose
(MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with
recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following
minimal prior treatment requirement:
- Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy).
Platinum resistant is defined as disease that has responded to initial chemotherapy but
demonstrates recurrence within a relatively short period of time (< 6 months) following
the completion of treatment.
- Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy).
Platinum sensitive is defined as the recurrence of active disease in a patient who has
achieved a documented response to initial platinum-based treatment and has been off
therapy for an extended period of time (≥ 6 months).
(MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with
recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following
minimal prior treatment requirement:
- Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy).
Platinum resistant is defined as disease that has responded to initial chemotherapy but
demonstrates recurrence within a relatively short period of time (< 6 months) following
the completion of treatment.
- Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy).
Platinum sensitive is defined as the recurrence of active disease in a patient who has
achieved a documented response to initial platinum-based treatment and has been off
therapy for an extended period of time (≥ 6 months).
Inclusion Criteria:
- Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer
meeting one of the following minimal prior treatment requirement (no limit to the
maximum number of prior treatments):
- Platinum Resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy)
with platinum resistant is defined as disease that has responded to initial
chemotherapy but demonstrates recurrence within a relatively short period of time
(< 6 months) following the completion of treatment.
- Platinum Sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage
therapy) with platinum sensitive is defined as the recurrence of active disease
in a patient who has achieved a documented response to initial platinum-based
treatment and has been off therapy for an extended period of time (≥ 6 months).
- Measurable disease per RECIST within the abdomen and pelvis. Extra-peritoneal disease
is permitted; however each lesion must be < 5 cm at the largest diameter.
- Available HLA haploidentical or better but not fully HLA-matched (2/4 or 3/4 antigens)
related donor (aged 18 to 75 years) with donor/recipient match based on a minimum of
intermediate resolution DNA based Class I typing of the A and B locus who is CMV
seropositive.
- At least 18 years of age, but not older than 75 years
- GOG Performance Status 0, 1, or 2
- Adequate organ function within 14 days of study registration (28 days for pulmonary
and cardiac) defined as:
- Hematologic: platelets ≥ 80,000 x 109/L and hemoglobin ≥ 9 g/dL, unsupported by
transfusions; absolute neutrophil count (ANC) ≥ 1000 x 109/L, unsupported by
G-CSF or granulocytes
- Creatinine: Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73m2 per
current institutional calculation formula
- Hepatic: AST and ALT ≤ 3 x upper limit of institutional normal
- Pulmonary Function: Oxygen saturation ≥ 90% on room air; PFT's required only if
symptomatic or prior known impairment - must have pulmonary function >50%
corrected DLCO and FEV1
- Cardiac Function: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI; no
uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
electrocardiographic evidence of acute ischemia or active conduction system
abnormalities
Exclusion Criteria:
- Able to be off prednisone or other immunosuppressive medications for at least 3 days
prior to FATE-NK100 cell infusion (excluding preparative regimen pre-medications)
- Agrees to the placement of an intraperitoneal port before the start of chemotherapy
and remains in place through Day 28 or longer
- Washout period of at least 14 days after any approved or experimental tumor directed
therapy prior to start of cyclophosphamide and fludarabine
- If history of brain metastases must be stable for at least 3 months after treatment -
A brain CT scan or MRI is only be required in subjects with known brain metastases at
the time of enrollment or in subjects with clinical signs or symptoms suggestive of
brain metastases
- Voluntary written consent prior to the performance of any research related procedures
Exclusion Criteria:
- Untreated brain metastases
- Myocardial Infarction (MI) within the previous 6 months
- Active autoimmune disease requiring systemic immunosuppressive therapy
- History of severe asthma and currently on chronic systemic medications (mild asthma
requiring inhaled steroids only is eligible)
- New or progressive pulmonary infiltrates on screening chest X-ray or chest CT scan
unless cleared for study by Pulmonary. Infiltrates attributed to infection must be
stable/improving (with associated clinical improvement) after 1 week of appropriate
therapy (4 weeks for presumed or documented fungal infections).
- Uncontrolled bacterial, fungal or viral infections with progression of clinical
symptoms despite therapy
- Known history of HIV positivity or active hepatitis C or B - chronic asymptomatic
viral hepatitis is allowed
- Received any investigational agent within the 14 days before the start of study
treatment (1st dose of fludarabine)
- Disease outside of the peritoneal cavity
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
Principal Investigator: Melissa Geller, MD
Phone: 612-624-0123
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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