Clinical trial · Interventional
Expanded Natural Killer Cell Infusion in Treating Younger Patients With Recurrent/Refractory Brain Tumors
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
NCT02271711CI-TRIAL-00046931completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Childhood Medulloblastoma | Childhood Medulloblastoma | CURATED_BROADER | 0.78 |
| Recurrent Ependymoma | Ependymoma | CURATED_BROADER | 0.78 |
| Recurrent Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Natural Killer Cell Therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (autologous ex vivo-expanded NK cells)
- description
- Patients receive autologous expanded NK cells IV into the ventricle over 3 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may continue treatment at the discretion of the treating physician if pseudo-progression or benefit of slowed progression is suspected.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Biological: Natural Killer Cell Therapy
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of natural killer (NK) cells
- timeFrame
- 4 weeks
- description
- Defined as the highest dose studied in which 6 patients have been treated at most 1 patient with dose limiting toxicities are observed. Toxicities will be summarized by tabulation in terms of type, grade and attribution for each dose level of each group of patients studied at the end of the trial.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.