Study of Intraventricular Infusions of Autologous ex Vivo-expanded NK Cells in Children With Recurrent/Refractory Malignant Posterior Fossa Tumors of the Central Nervous System. NOAH's (New Opportunity, Advancing Hope) Protocol
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|ClinicalTrials.gov Identifier: NCT02271711|
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : June 21, 2018
The goal of this clinical research study is to learn if infusions of a particular type of patients' own white blood cells called natural killer (NK) cells can reliably and safely be given to patients with brain tumors after the cells have been through a procedure to expand (increase) their numbers.
Researchers also want to learn if NK cells infused through the ommaya reservoir can help to control the disease in patients with advanced brain tumors. The ommaya reservoir is a catheter system through which NK cells will be infused directly into areas of the brain called the fourth ventricle or the lateral.
This is the first study of intraventricular NK cell infusions (infusions into the ventricle of the brain) in humans.
|Condition or disease||Intervention/treatment||Phase|
|Brain Cancer||Biological: Natural Killer (NK) Cells||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Intraventricular Infusions of Autologous ex Vivo-expanded NK Cells in Children With Recurrent/Refractory Malignant Posterior Fossa Tumors of the Central Nervous System. NOAH's (New Opportunity, Advancing Hope) Protocol|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Natural Killer (NK) Cell Infusions
Patient receives 3 cycles of Natural Killer (NK) cell infusions. Each cycle 4 weeks duration. During the first 3 weeks (Day 1-7 weekly) NK cells infused at Day 1, 3 and 5 (+/- 2 days). The 4th week will be a rest week. Follow-up visit will be 30 days from last infusion (cycle 3). Starting dose level of NK-cell number per infusion is 10^6/m^2. Infusions given through ommaya reservoir catheter.
Biological: Natural Killer (NK) Cells
Starting dose level of NK-cell number per infusion is 10^6/m^2. Infusions given through ommaya reservoir catheter. Participants receive the NK cells 3 times a week (at least 1 day apart) for the first 3 weeks in each 4-week cycle.
- Maximum Tolerated Dose (MTD) of Autologous Natural Killer (NK) Cells [ Time Frame: 4 weeks ]Maximum Tolerated Dose (MTD) is maximum dose at which fewer than one-third of patients experience a Dose Limiting Toxicity (DLT) during cycle 1 of therapy. MTD defined as highest dose studied in which six patients have been treated and at most one patient with DLTs are observed.
- Antitumor Activity of Autologous NK Cell Administration [ Time Frame: 7 days after 3, 4 week cycles ]Antitumor activity based on imaging and cytology. Measurable disease defined as presence of at least one lesion that can be accurately measured in two dimensions, each of which measure at least 10 mm: product of longest diameter and longest perpendicular diameter. Evaluable disease defined as at least one lesion that cannot be accurately measured in at least one dimension, or positive CSF cytology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271711
|Contact: Soumen Khatua, MD||713-792-3280|
|Contact: Clinical Research Operations UT MD Anderson||713-792-7734||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: MD Anderson Health Information Specialist 877-632-6789|
|Principal Investigator:||Soumen Khatua, MD||M.D. Anderson Cancer Center|