The investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm\^3 four weeks after stem cell reinfusion in high grade glioma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event
The study will provide preliminary evidence of efficacy if ≥5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ≥300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.
Time frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
Number of lymphocyte stem cells that can be harvested from this patient population
Time frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.
Time frame: 4 weeks after stem cell reinfusion
Duration of lymphocyte rise following stem cell reinfusion
Time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
Changes in lymphocyte subtypes following collection and reinfusion
Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months.
Time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
Changes in series of cytokine levels following collection and reinfusion
Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months.
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Time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events
the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting.
Time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)