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NCT02490930 · ClinicalTrials.gov registry record · Early Phase 1
A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT02490930 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 5 participants.
The verdict
NCT02490930, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study 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.
Interventions
- DRUG Fingolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-09 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02490930
The ClinicalTrials.gov registry entry for NCT02490930 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fingolimod is the first listed.
NCT02490930 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02490930 about?
NCT02490930 is a clinical study titled "A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma". 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 ...
What is the current status of trial NCT02490930?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2015-07. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02490930?
The interventions under investigation include: Fingolimod (DRUG).
Who is sponsoring clinical trial NCT02490930?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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