Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab
- Conditions
- Epidural Spinal TumorsCancer
- Interventions
- Registration Number
- NCT05204290
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
- Prior radiation therapy or surgery to index lesion.
- Patients with lymphoma, multiple myeloma, germinomas, seminomas, Wilm's tumors, and Ewing's sarcomas will be excluded.
- Muscle strength of ≤ 3 out of 5 on neurologic exam that correlates with level of the involved spinal cord.
- Retropulsed compression fracture.
- Patients with a contraindication to pembrolizumab.
- Patients may not be receiving any other investigational agents.
- Patients with symptomatic, brain metastases, as determined by the study PI, that could confound the neurologic exam, should be excluded.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because both radiation and pembrolizumab can be harmful to the developing fetus. Because there is an unknown but potential risk for adverse events, pregnant women are not allowed to participate in this study, in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding should be discontinued.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic Body Radiotherapy and Pembrolizumab Treatment Stereotactic Body Radiation Therapy MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab Stereotactic Body Radiotherapy and Pembrolizumab Treatment Blood draws MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab Stereotactic Body Radiotherapy and Pembrolizumab Treatment Pembrolizumab MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab
- Primary Outcome Measures
Name Time Method Number of Participants Completing Stereotactic Body Radiation Therapy and One Cycle of Pembrolizumab 6 months 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.
- Secondary Outcome Measures
Name Time Method Accrual Rate Every 2 months, up to 20 months Number of enrolled per month on the study intervention.
Change Thecal Sac Patency - (Percentage) at 2 months and 6 months after intervention 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.
Incidences of Compression Fractures 1 month after intervention and 6 months after intervention 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
Changes in Plasma At baseline, 2 months and 6 months after intervention 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
Number of Participants Experiencing Improvement in Pain - Numeric Pain Rating Scale (NPRS) At baseline and up to 20 months 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.
Quality of Life - European Organization for Research and Treatment of Cancer QoL Group Bone Metastases Module (QLQ-BM22) Baseline, 2 months and 6 months 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.
Trial Locations
- Locations (1)
Wake Forest Baptist Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States