Brief Title
Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients
Official Title
Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients (a Phase I Study)
Brief Summary
This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex
vivo-generated allogeneic natural killer (NK) cells with or without preceding
non-myeloablative conditioning chemotherapy.
Detailed Description
This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex
vivo-generated allogeneic natural killer (NK) cells with or without preceding
non-myeloablative conditioning chemotherapy.
This study is a phase I safety and feasibility study in a series of 12 patients who are
suffering from recurrent ovarian, fallopian tube or primary peritoneal cancer. Prior to NK
cell infusion, a laparoscopy is performed to place a catheter in the peritoneal cavity. The
first cohort of three patients will receive an intraperitoneal infusion of allogeneic UCB-NK
cells generated ex vivo from CD34+ hematopoietic progenitor cells obtained from an allogeneic
UCB unit without a preparative regimen. In the second group of three patients the same UCB-NK
cell dosage will be given with a preparative regimen of four days non-myeloablative
immunosuppressive conditioning regimen with cyclophosphamide and fludarabine (CyFlu). If no
severe toxicity is seen in these 6 patients, an extension cohort of 6 patients will be
included to answer the secondary objective.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of treatment emergent adverse events
Secondary Outcome
in vivo lifespan of the infused UCB-NK cells
Condition
Recurrent Ovarian Carcinoma
Intervention
UCB-NK cells
Study Arms / Comparison Groups
NK-cells without preparative regimen
Description: NK-cells without preparative regimen
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
12
Start Date
June 4, 2019
Completion Date
May 2020
Primary Completion Date
May 2020
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from their second recurrence of ovarian, fallopian tube or primary
peritoneal cancer, with an elevated serum level of CA-125 on two successive time
points with 28 days in between, reaching a value of more than 2 times nadir and above
35 U/ml without gastrointestinal symptoms.
- Able to undergo laparoscopic IP port placement and IP treatment administration
- Adequate organ function
- Age 18 years or older
- Age under 76 years.
- Karnofsky performance status >70% (see appendix 2)
- Life expectancy > 6 months
- At least 28 days after last anti cancer treatment, before start of preparative regimen
- Written informed consent
- Availability of a partially HLA-matched UCB unit
Exclusion Criteria:
- Patients on immunosuppressive drugs
- Patients with active infections (viral, bacterial or fungal) that requires specific
therapy. Acute anti-infectious therapy must have been completed within 14 days prior
to study treatment
- Laparoscopic adhesion score >4 out of 9.
- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive
heart failure or symptomatic ischemic heart disease (appendix 4)
- Severe pulmonary dysfunction (CTCAE III-IV) (appendix 4)
- Severe renal dysfunction (MDRD<50) (appendix 4)
- Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level)
(appendix 4)
- Severe neurological or psychiatric disease
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
, 0031 24 361 3223, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03539406
Organization ID
NL60937.000.17
Responsible Party
Sponsor
Study Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
Study Sponsor
, ,
Verification Date
September 2019