An Early Phase 1 interventional study of Radiation therapy and Temozolomide in Astrocytoma, Brainstem Glioma and Ependymoma, sponsored by Washington University School of Medicine. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-20.
Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Treatment
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
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Normal bone marrow and organ function as defined below:
Exclusion Criteria:
* Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide * Focal radiation therapy: standard of care dose daily for approximately 6 weeks * Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation * 2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient * Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide
Radiation: Radiation therapy · Drug: Temozolomide · Procedure: Stem cell collection · Procedure: Stem cell infusion
Also known as: Temodar®
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.
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)
No study locations are listed for this record.
This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine