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Natural Killer cel therapie tegen teruggekeerde eierstokkanker.


- candidate number28163
- NTR NumberNTR6970
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-nov-2017
- Secondary IDsKWF 2017 10100 / EUDRACT 2016 000 299 78 /  ABR 60937 000 17
- Public TitleNatural Killer cel therapie tegen teruggekeerde eierstokkanker.
- Scientific TitleIntraperitoneal Natural Killer cell therapie against recurrent ovarian cancer
- ACRONYMINTRO-studie
- hypothesisNatural killer cells are cells of the innate immunesystem and can kill tumor cells without prior sensitization. By infusing these cells through a catheter in the intraperitoneal cavity, ovarian carcinoma cells can be traced and killed. This phase 1 study is designed to look at the safety and toxicity.
- Healt Condition(s) or Problem(s) studiedImmune therapy, Recurrent ovarian carcinoma
- 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
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mrt-2018
- planned closingdate1-sep-2021
- Target number of participants12
- InterventionsIntraperitoneal natural killer cell therapy with and without preconditioning chemotherapy regimen.
- Primary outcomeSafety and toxicity of intraperitoneal NK cells.
- Secondary outcomeIn vivo detection and expansion of the transfused UCB-NK cells, detection of biological NK cell activity and effect on CA-125 levels
- TimepointsTrial will start including on 1st of march 2018.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Harry Dolstra
- CONTACT for SCIENTIFIC QUERIES Janneke Hoogstad
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summaryThis 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 between 1.5x 109 and 3x109 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. The primary aim of our study is to evaluate safety and toxicity of intraperitoneal infusion of ex vivo-expanded NK cells from CD34+ umbilical cord blood (UCB) progenitor cells with and without a preceding non-myeloablative immunosuppressive conditioning regimen in patients suffering from recurrent ovarian, fallopian tube or primary peritoneal cancer. Secondary objectives are to compare the in vivo lifespan, expansion and biological activity of intraperitoneal infused NK cell products with and without preparative chemotherapy, and effects on disease.
- Main changes (audit trail)
- RECORD8-nov-2017 - 1-feb-2018


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