Status:
COMPLETED
Expanded Natural Killer Cell Infusion in Treating Younger Patients With Recurrent/Refractory Brain Tumors
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Childhood Medulloblastoma
Recurrent Ependymoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. To establish the safety, feasibility, efficacy, and maximum tolerated dose (MTD) of administering autologous natural killer (NK) cells that have been propagated ex vivo with ar...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02271711
Start Date
March 17 2015
End Date
August 28 2020
Last Update
September 2 2020
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030