Expanded Natural Killer Cell Infusion in Treating Younger Patients With Recurrent/Refractory Brain Tumors

Completed · Phase 1

Conditions studied: Recurrent Childhood Medulloblastoma, Recurrent Ependymoma, Recurrent Medulloblastoma

In brief

This phase I trial studies the side effects and best dose of expanded natural killer cells in treating younger patients with brain tumors that have come back or do not respond to treatment. Infusing a particular type of a patient's own white blood cells called natural killer cells that have been through a procedure to expand (increase) their numbers may work in treating patients with recurrent/refractory brain tumors.

Key facts

Study ID

NCT02271711

Run by

M.D. Anderson Cancer Center

People needed

12

Starts

2015-03-17

Expected to finish

2020-08-28

Last updated by the study team

2020-09-02

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis: patients with recurrent/refractory medulloblastoma (MB), atypical teratoid (AT)/rhabdoid tumors (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
• Patient must have either measurable or evaluable tumor
• Presence of or determined by neurosurgery to be a candidate for an implanted catheter in the ventricles to receive NK cell infusion
• Life expectancy of at least 12 weeks in opinion of principal investigator (PI) and/or designee
• 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)
• Neurologic deficits must have been relatively stable for a minimum of 1 week prior to study enrollment
• Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy
• Patient must be 4 weeks off any palliative radiation or craniospinal radiation
• Absolute neutrophil count (ANC) of >= 1000/uL
• Platelet count of >= 30,000
• Hemoglobin of >= 9.0 g/dl
• Patients with a seizure disorder may be enrolled if well-controlled and on non-enzyme inducing anticonvulsants
• Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent

You may not qualify if…

• Enrolled in another treatment protocol
• Evidence of untreated infection
• Extra-cranial metastasis
• Chronic corticosteroid dependence (except replacement therapy)
• Extensive disease, disease location, and/or co-morbid condition that the PI or designee considers unsafe for surgical intervention of NK cell infusion
• Pregnant or lactating women

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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