A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma
Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
A recent prospective multicenter study by Dr. Grossman demonstrated that 40% of patients with
high grade glioma undergoing radiation and chemotherapy developed severe and persistent
lymphopenia (CD4 counts <200 cells/mm3). This lymphopenia lasted for twelve months following
radiation treatment and on multivariate analysis was associated with shorter survival. Our
group has data that strongly suggests that this lymphopenia is secondary to the inadvertent
radiation of circulating lymphocytes as they pass through the radiation beam. Investigators
propose the use of FDA approved for multiple sclerosis, fingolimod to signal lymphocytes to
leave the circulation prior to the initiation of radiation. It is a functional antagonist of
the sphingosine-1-phosphate receptor (S1PR) pathway and prevents lymphocyte egress from
secondary lymphoid organs.
Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and
temozolomide and will be discontinued immediately upon completion of the six weeks of
therapy. The primary objective is to evaluate if fingolimod can be safely combined with
radiation and temozolomide. Secondary endpoint is total lymphocyte counts (TLC) for the
proposed study participants. Investigators expect that patients receiving radiation and
temozolomide plus fingolimod have a recovery of lymphocyte counts to 80% of baseline within
four months, reference to historical control in which sustained lymphopenia lasted for twelve
months.
Phase:
Early Phase 1
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins