Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients
NCT ID: NCT03539406
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2019-06-04
2023-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NK-cells without preparative regimen
NK-cells without preparative regimen
UCB-NK cells
Intraperitoneal allogeneic UCB-NK cells infusion
NK-cells with preparative regimen
NK-cells with preparative regimen
UCB-NK cells
Intraperitoneal allogeneic UCB-NK cells infusion
Chemotherapy
Cyclofosfamide/fludarabine treatment
Interventions
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UCB-NK cells
Intraperitoneal allogeneic UCB-NK cells infusion
Chemotherapy
Cyclofosfamide/fludarabine treatment
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboudumc
Nijmegen, , Netherlands
Countries
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Other Identifiers
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NL60937.000.17
Identifier Type: -
Identifier Source: org_study_id
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