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Trial record 1 of 1 for:    NCT02271711
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Fourth Ventricle Infusions of Autologous Ex Vivo Expanded NK Cells in Children With Recurrent Posterior Fossa Tumors

This study is currently recruiting participants.
Verified November 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02271711
First Posted: October 22, 2014
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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 Intervention Phase
Brain Cancer Biological: Natural Killer (NK) Cells Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Nervous System NOAH's (New Opportunity, Advancing Hope) Protocol

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 24
Actual Study Start Date: March 2015
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: < 22 years at the time of recurrence or progression
  2. Diagnosis: Patients with recurrent/refractory MB, AT/RT or ependymoma involving the brain and/or spine at original diagnosis or relapse. They must have histological verification at diagnosis and/or relapse. Patient must have presented with these tumors in the posterior fossa (PF) or relapsed in the PF.
  3. Patient must have either measurable or evaluable tumor.
  4. Presence of or determined by neurosurgery to be a candidate for an implanted catheter in the ventricles to receive NK cell infusion.
  5. Life expectancy of at least 12 weeks in opinion of PI and/or designee.
  6. Lansky score of 50 or greater if </=16 years of age or a Karnofsky score of 50 or greater if > 16 years of age (NOTE: Patients who are unable to walk because of paralysis, but who are in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score).
  7. Neurologic deficits must have been relatively stable for a minimum of 1 week prior to study enrollment.
  8. Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy.
  9. Patient must be 4 weeks off any palliative radiation or craniospinal radiation
  10. Adequate bone marrow function defined by an ANC of >/= 1000/µL, platelet count of >/= 30,000 and hemoglobin of >/= 9.0 g/dl
  11. Patients with a seizure disorder may be enrolled if well-controlled and on non- enzyme inducing anticonvulsants
  12. Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent

Exclusion Criteria:

  1. Enrolled in another treatment protocol
  2. Evidence of untreated infection
  3. Extra-cranial metastasis
  4. Chronic corticosteroid dependence (except replacement therapy)
  5. Extensive disease, disease location, and/or co-morbid condition that the PI or designee considers unsafe for surgical intervention of NK cell infusion
  6. Pregnant or lactating women
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Soumen Khatua, MD 713-792-3280
Contact: Clinical Research Operations UT MD Anderson 713-792-7734 CR_Study_Registration@mdanderson.org

Locations
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      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Soumen Khatua, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02271711     History of Changes
Other Study ID Numbers: 2013-0765
NCI-2014-02677 ( Registry Identifier: NCI CTRP )
First Submitted: October 17, 2014
First Posted: October 22, 2014
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by M.D. Anderson Cancer Center:
Brain Cancer
Brain tumor
Recurrent posterior fossa tumors
Central nervous system
CNS
Artificial antigen- presenting cells
aAPC
Natural killer cells
NK
Ommaya reservoir

Additional relevant MeSH terms:
Brain Neoplasms
Infratentorial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases