Phase
Condition
Ovarian Cysts
Carcinoma
Treatment
UCB-NK cells
Chemotherapy
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients suffering from their second recurrence of ovarian, fallopian tube orprimary peritoneal cancer, with an elevated serum level of CA-125 on two successivetime points with 28 days in between, reaching a value of more than 2 times nadir andabove 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 preparativeregimen
Written informed consent
Availability of a partially HLA-matched UCB unit
Exclusion
Exclusion Criteria:
Patients on immunosuppressive drugs
Patients with active infections (viral, bacterial or fungal) that requires specifictherapy. Acute anti-infectious therapy must have been completed within 14 days priorto study treatment
Laparoscopic adhesion score >4 out of 9.
Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestiveheart 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
Study Design
Study Description
Connect with a study center
Radboudumc
Nijmegen,
NetherlandsSite Not Available

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