Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborators: Dutch Cancer Society; KWF

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