This clinical trial tests the safety and side effects of temporally-modulated pulsed radiation therapy (TMPRT) in treating patients with gliomas that have been treated with radiation therapy in the past, have come back (recurrent), and have a genetic change in the IDH gene (IDH-mutant). Standard radiation therapy is typically delivered once daily in a continuous manner, during which patients lie on a treatment table for approximately 10 minutes. TMPRT is a new way of delivering radiation therapy by breaking each daily treatment into 10 segments, or “pulses,” with about 3 minutes of rest in between each pulse of radiation. TMPRT may be more efficient at killing tumor cells while also reducing damage to normal brain tissue and blood vessels.
Additional locations may be listed on ClinicalTrials.gov for NCT05393258.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of temporally-modulated pulsed radiation therapy (TMPRT) for reirradiation of recurrent IDH-mutant gliomas after prior radiation therapy (RT).
SECONDARY OBJECTIVES:
I. To evaluate overall toxicities of reirradiation using TMPRT
II. To evaluate the impact of reirradiation using TMPRT on patient-reported symptom burden and symptom interference.
III. To evaluate the impact of reirradiation using TMPRT on patient-reported quality of life.
IV. To evaluate progression-free survival after reirradiation using TMPRT at one year.
V. To evaluate overall survival after reirradiation using TMPRT at one year.
EXPOLORATORY OBJECTIVE:
I. To evaluate the effect TMPRT on circulating T-cells and myeloid cells.
OUTLINE:
Patients undergo TMPRT over 30 to 45 minutes daily, Monday through Friday for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) during screening.
After completion of study treatment, patients are followed up at 6 weeks, 4 months, and 10 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorJiayi Huang