Clinical Trial: Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

Brief Summary: 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.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome: 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 [ Time Frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: Up to 6 months after stem cell reinfusion (approximately 9 months) ]
    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.
  • Changes in series of cytokine levels following collection and reinfusion [ Time Frame: Up to 6 months after stem cell reinfusion (approximately 9 months) ]
    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.
  • Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events [ Time Frame: Up to 6 months after stem cell reinfusion (approximately 9 months) ]
    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.


Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: November 23, 2016
Date Started: January 2017
Date Completion: February 2018
Last Updated: February 16, 2017
Last Verified: February 2017