REMIND Maintenance Radiotherapy for Newly Diagnosed Glioblastoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
REMIND is a single-center feasibility study testing maintenance radiotherapy in adult patients with newly diagnosed glioblastoma.
Participants will be consented before starting standard-of-care concurrent temozolomide and radiotherapy. After enrollment, participants will enter an observational lead-in phase while receiving standard-of-care therapy off study. Approximately 4 weeks after temozolomide, participants will receive one study-specific 2 Gy fraction of maintenance radiotherapy directed at the post-operative cavity and areas of prior enhancing disease.
The study will evaluate the safety and feasibility of delivering maintenance radiotherapy. Blood samples will also be collected before and after maintenance radiotherapy to descriptively compare myeloid-derived suppressor cell frequency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diagnosis of glioblastoma according to WHO classification criteria for which standard-of-care surgical resection, concurrent temozolomide and radiotherapy, and adjuvant temozolomide is planned
Planning to receive standard-of-care radiotherapy with a biological effective dose of 60 Gy or less in 30 fractions
Age 18 years or older at the time of consent
Karnofsky performance status of 70 or higher
Disqualifiers
Pregnant or breastfeeding
Presence of brain stem involvement within the planning target volume from the initial course of standard-of-care radiotherapy
Prior radiation therapy to the brain
Contraindication to MRI or CT
Trial design
Design model
Single group
Treatments tested in this trial
Maintenance Radiotherapy
RadiationMaintenance radiotherapy consists of a single 2 Gy fraction of radiation delivered approximately 4 weeks after standard-of-care temozolomide. Intensity-modulated radiotherapy will be directed at the post-operative cavity and areas where previous enhancing disease was identified after surgical resection.
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: Maintenance RadiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number and Percentage of Participants Who Complete the Single 2 Gy Fraction of Maintenance Radiotherapy
Feasibility will be assessed by the number and percentage of enrolled participants who complete the study-specific single 2 Gy fraction of maintenance radiotherapy.
Time frame
From enrollment through completion of maintenance radiotherapy, approximately 4 weeks after standard-of-care temozolomide2
Occurrence of CTCAE Grade 4 or 5 Toxicities Related to the Single 2 Gy Maintenance Radiotherapy Fraction
Safety will be assessed by the occurrence of CTCAE Grade 4 or 5 toxicities related to the experimental single 2 Gy maintenance radiotherapy fraction.
Time frame
From maintenance radiotherapy through 28 days after study treatmentSecondary outcomes
1
Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency
Within 2 weeks before maintenance radiotherapy and within 1 week after maintenance radiotherapy
Time frame
The frequency of myeloid-derived suppressor cells in peripheral blood will be descriptively compared before and after maintenance radiotherapy. The percentage change from pre-maintenance radiotherapy will be recorded for each participant.Other outcomes
1
Percentage Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency After Maintenance Radiotherapy
The frequency of myeloid-derived suppressor cells in peripheral blood will be measured within 2 weeks before maintenance radiotherapy and within 1 week after maintenance radiotherapy. The percentage change from pre-maintenance radiotherapy will be recorded for each participant.
Time frame
Within 2 weeks before maintenance radiotherapy and within 1 week after maintenance radiotherapySponsors and contacts
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Source ClinicalTrials.gov