Intraperitoneal infusion of ex vivo cultured allogeneic Natural Killer cells in recurrent ovarian carcinoma patients.

Completed

• Conditions: Ovarian carcinoma; 10038594

• Registration Number: NL-OMON45699
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-08-28
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and toxicity of intraperitoneal UCB-NK cell infusion in combination with<br /><br>IL-2 support, with versus without a preceding lymphodepleting conditioning<br /><br>regimen</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are in vivo lifespan, proliferation and functional<br /><br>activity of infused NK cells and preliminary effect on peritoneal disease using<br /><br>CA-125 serum levels.</p><br>