The purpose of this research study is to find out what effects (good and bad) Pembrolizumab and radiosurgery have on participants with high-grade epidural disease of the spine.
Primary Objective: To determine the feasibility of patients completing stereotactic body radiation therapy and at least one (1) cycle of Pembrolizumab. Secondary Objectives: * Evaluate the radiographic response after decompressive stereotactic body radiation therapy and Pembrolizumab by calculating the improvement in thecal sac patency (see 5.2.1). * Evaluate accrual rate, * Evaluate pain relief. * Evaluate quality of life. * Evaluate cumulative incidence of adverse events. * Evaluate potential correlative blood biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Pembrolizumab will be delivered at the discretion of the patient's medical oncologist within 6 weeks after finishing SBRT. If a patient is already receiving pembrolizumab at the time of enrollment, then SBRT should not start sooner than 5 days after the last pembrolizumab infusion.
patients will undergo CT simulation and will be immobilized in either a BodyFix® or long thermoplastic mask depending on the location of the lesion. 1.25mm slices will be acquired. Dose and fractionation will be at the discretion of the treating radiation oncologist (as will the constraint to the spinal cord).
Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy.
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Number of Participants Completing Stereotactic Body Radiation Therapy and One Cycle of Pembrolizumab
A 95% confidence interval for the primary outcome, the feasibility of patients completing stereotactic body radiation therapy and at least one cycle of Pembrolizumab, will be calculated.
Time frame: 6 months
Change Thecal Sac Patency - (Percentage)
The percentage of thecal sac patency, which will be calculated as the ratio of the thecal sac area at the level of greatest epidural disease to the estimated pre-compression thecal sac area. The estimated pre-compression thecal sac area will be calculated by averaging the area of the thecal sac at one spinal level above and one spinal level below the level of the compression.
Time frame: at 2 months and 6 months after intervention
Accrual Rate
Number of enrolled per month on the study intervention.
Time frame: Every 2 months, up to 20 months
Number of Participants Experiencing Improvement in Pain - Numeric Pain Rating Scale (NPRS)
Using the Numeric Pain Rating Scale the number of participants that experience a clinically significant improvement in pain defined as either a 33% decrease in pain score or an absolute decrease from baseline of 2 points. Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Time frame: At baseline and up to 20 months
Quality of Life - European Organization for Research and Treatment of Cancer QoL Group Bone Metastases Module (QLQ-BM22)
The 22-item EORTC QLQ-BM22 questionnaire assesses disease symptoms related to bone metastasis, including painful sites, functional interference, painful characteristics, and psychosocial aspects as multi-item scales. Scaled items from one (not at all) to four (very much). Score range is from 0 to 100. A higher score in the case of symptom scales is indicative of greater distress, while a higher score in the case of functional scales indicates greater functional ability.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, 2 months and 6 months
Incidences of Compression Fractures
New or worsening after stereotactic body radiation therapy, rate of pain flare by physician assessment and cumulative incidences of radiation myelitis will be assessed. Radiation myelitis will be defined by the study PI using clinical and radiographic techniques will be calculated. For discrete variables, the proportions and counts will be calculated for each visit. For continuous variables, means, standard deviations, medians, the first quartiles, the third quartiles, and ranges will be calculated for each visit. The 95% confidence intervals will be also estimated
Time frame: 1 month after intervention and 6 months after intervention
Changes in Plasma
Plasma will be tested for histamine, Calcitonin gene-related peptide (CGRP), and substance P which will characterize bone turnover markers, specifically for N-terminal propeptide of type 1 procollagen (P1NP; bone formation) and C-terminal telopeptide of type 1 collagen (CTX; bone resorption). For discrete variables, the proportions and counts will be calculated for each visit. For continuous variables, means, standard deviations, medians, the first quartiles, the third quartiles, and ranges will be calculated for each visit. The 95% confidence intervals will be also estimated
Time frame: At baseline, 2 months and 6 months after intervention