Early-Phase Study of Targeted Natural Killer Cell Therapy for Children and Young Adults With Recurrent, Progressive or Refractory Brain Tumors
Phase: Recruiting
First Posted: March
Condition(s): Recurrent, Progressive or Refractory Brain Tumors
NCT Number: NCT04254419 Other Study ID Number(s): NK Brain Tumor
What Is the Purpose of This Study?
To see if it is safe and feasible to treat malignant brain tumors with donor natural killer (NK) cells. The hope is to see if the NK cells are effective against the tumors and improve quality of life.
Who Can Take Part in This Study?
People who may be eligible for this study:
- Age: 1 to 39 years old.
- Diagnosis: Must have a difficult-to-treat brain tumor, except for certain types (DMG/DIPG).
- Procedure Eligibility: Must be able to receive an Ommaya reservoir or a programmable VP shunt.
- Surgery & Tumor Size: Having a measurable tumor after surgery is not required, but the resection area must meet size requirements for treatment.
- Physical Ability: Must have a certain level of physical function (can use a wheelchair if unable to walk).
- Blood & Organ Function: Must have healthy bone marrow, liver, kidney and blood clotting function.
- Seizures: Allowed if well controlled.
- Stable Neurologic Condition: No worsening symptoms for at least one week.
- Pregnancy Prevention: Must use birth control during and six months after the study.
For a full list of eligibility requirements, visit https://clinicaltrials.gov/study/NCT04254419
What Will Happen During This Study?
- Patients will have multiple visits before, during and after treatment with the NK cells. These visits can include physical exams, blood tests, MRIs and collection of cerebrospinal fluid.
- They will receive NK cell infusions weekly for 3 weeks, followed by 1 week of rest. This is called a cycle.
- They will receive up to 12 cycles of treatment, depending on how their tumor responds.
- After treatment ends, patients will continue to follow up with the study doctor for up to 5 years to see how they are doing.
Principal Investigator
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