Trials / Completed
CompletedNCT03539406
Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients
Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients (a Phase I Study)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UCB-NK cells | Intraperitoneal allogeneic UCB-NK cells infusion |
| DRUG | Chemotherapy | Cyclofosfamide/fludarabine treatment |
Timeline
- Start date
- 2019-06-04
- Primary completion
- 2023-05-01
- Completion
- 2023-09-01
- First posted
- 2018-05-29
- Last updated
- 2024-08-09
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03539406. Inclusion in this directory is not an endorsement.