Qualitative, Qualitative, and Functional Studies Over the First Year in Measuring Immune System Response During the First Year of Therapy in Patients With Brain Tumors
Completed
Conditions studied: Astrocytoma, Glioma, Oligodendroglioma
In brief
This research trial studies qualitative, qualitative, and functional studies over the first year in measuring immune system response in patients with brain tumors. Measuring the number of immune cells, whether these immune cells work correctly, and response to 2 vaccines at several times during the first year of treatment may help find out how active the immune system responds to fight infection and cancer.
Key facts
- Study ID
- NCT02747407
- Run by
- Wake Forest University Health Sciences
- People needed
- 55
- Starts
- 2016-05-01
- Expected to finish
- 2021-09-09
- Last updated by the study team
- 2021-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinically or histologically diagnosed primary central nervous system astrocytoma or oligodendroglioma of World Health Organization grade II, III or IV
- Anticipated to undergo treatment with concurrent chemoradiation with conformal external beam radiotherapy in combination with low-dose temozolomide (75 mg/m\^2) followed by adjuvant temozolomide (150-200 mg/m\^2)
- Able to provide informed consent
- Karnofsky performance status >= 50%
- Willing and able to receive the tetanus toxoid and hepatitis vaccination (though prior vaccination with either vaccine is not a contraindication to eligibility)
You may not qualify if…
- Concurrent enrollment on an experimental study involving an agent whose primary mechanism of action is the immune system (i.e. immune checkpoint inhibition, oncologic vaccine, or other immune-directed therapies); Note: patients enrolled on an experimental study or receiving another concurrent treatment in addition to standard chemoradiation whose primary mechanism of action is NOT the immune system will be eligible for enrollment
- Patients unable to receive tetanus toxoid vaccination
- Guillain-Barré syndrome =< 6 weeks after previous dose of a tetanus toxoid-containing vaccine; unstable neurologic condition (e.g., cerebrovascular events and acute encephalopathic conditions) which does not include the patient's primary brain tumor; history of an Arthus reaction following a previous dose of a tetanus toxoid-containing and/or diphtheria toxoid-containing vaccine
- Patients unable to receive hepatitis vaccination
Where it is running
- Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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