Clinical Trial: Fourth Ventricle Infusions of Autologous Ex Vivo Expanded NK Cells in Children With Recurrent Posterior Fossa Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase I Study of Fourth Ventricle Infusions of Autologous Ex Vivo-Expanded NK Cells in Children With Recurrent/Refractory Malignant Posterior Fossa Tumors of the Central N

Brief Summary:

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 NK cells infused into the fourth ventricle of the brain in humans.


Detailed Summary:

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of NK cells based on when you join this study. Up to 4 dose levels of NK cells will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of NK cells is found.

NK Cell Collection, Expansion, and Infusion:

Blood (up to 10 tablespoons) will be drawn through your central venous catheter if you have one, or through a needle stick.

Your NK cells will then be processed in The Cell Therapy Laboratory GMP facility at MD Anderson to make increased numbers of NK cells. Leftover blood from this process and/or extra NK cells beyond what is needed for the study will be used to study the appearance and function of your NK cells.

Your NK cells will be destroyed if the cells show some form of abnormal cell growth during the process and are unsafe for infusion, if you are found to not be eligible to receive the infusions, or if you leave the study early.

If you do not already have an Ommaya catheter that has been placed in the lateral or fourth ventricle of your brain, you will have one placed before receiving the NK cells. You will sign a separate surgical consent form that will describe the procedure in more detail.

You will receive the NK cells 1 time a week (at least 3 days apart) for the first 3 weeks in each 4-week cycle. These infusions w
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: October 17, 2014
Date Started: March 2015
Date Completion: March 2020
Last Updated: April 4, 2017
Last Verified: April 2017