The objective is to evaluate safety, toxicity and expansion of intraperitoneally infused UCB-derivedex vivo-generated NK cells in patients diagnosed with recurrent ovarian cancer. Infusion with and without lymphodepleting chemotherapy will be…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and toxicity of intraperitoneal UCB-NK cell infusion in combination with
IL-2 support, with versus without a preceding lymphodepleting conditioning
regimen
Secondary outcome
Secondary objectives are in vivo lifespan, proliferation and functional
activity of infused NK cells and preliminary effect on peritoneal disease using
CA-125 serum levels.
Background summary
Recurrent ovarian carcinoma is incurable, but prolonged survival upon therapy
is possible in some patients. The 5-year survival is 46% for all stages of
ovarian cancer, and 28% for advanced stage disease. Notably, almost 70% of
women with ovarian cancer present with stage III or IV disease for which the
rate of recurrence is 70-90%. As most women with relapsed or metastatic cancer
will die of progressive disease, there is a medical need for novel therapeutic
strategies.
Study objective
The objective is to evaluate safety, toxicity and expansion of
intraperitoneally infused UCB-derived
ex vivo-generated NK cells in patients diagnosed with recurrent ovarian cancer.
Infusion with and without lymphodepleting chemotherapy will be compared for
UCB-NK cell persistence and expansion that is crucial for clinical benefit.
Study design
Phase 1 safety study in 4 cohorts of 3 patients. The first 3 patients will
receive NK cell infusion alone, the second cohort will get NK cell infusion
with a preparative chemotherapy regimen. In the extension cohort of 6 patients
we will look at NK cell expansion with and without preparative chemotherapy, to
be able to decide whether preparitive chemotherapy is neccesary.
Intervention
Intraperitoneal UCB-NK cell infusion of UCB-NK cells in combination with IL-2
support, with versus without a preceding lymphodepleting conditioning regimen.
Study burden and risks
All patients start with intraperitoneal placement of the IP catheter per
laparoscopy in daycare. The first group will be admitted in the hospital for 14
days for chemotherapy and will receive the intraperitoneal NK cell infusion in
the same setting. The second group will have the intraperitoneal NK cell
infusion in daycare. All patients will be seen for medical checkup, blood
collection and peritoneal fluid collection on day 7, 14, 21 and 28, and for the
first two on day 56.
Geert Grooteplein 8
Nijmegen 6525 GA Nijmegen
NL
Geert Grooteplein 8
Nijmegen 6525 GA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patient with a second recurrence of ovarian cancer, based on increasing CA-125 levels, without symptoms. Patients are included after palliative chemotherapy for their first recurrence. Patients must have a life expectancy of >6 months and are only enrolled after prior given written informed consent. Patients should be able to undergo a laparoscopy.
Exclusion criteria
Patients with active infections or serious organ failure are excluded. Patients on immunesuppressive drugs and with recent chemotherapy (<28days ago).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-000299-78-NL |
| CCMO | NL60937.000.17 |
| OMON | NL-OMON20648 |