Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab
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|ClinicalTrials.gov Identifier: NCT05204290|
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : May 6, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Epidural Spinal Tumors Cancer||Drug: Pembrolizumab Radiation: Stereotactic Body Radiation Therapy Other: Blood draws||Early Phase 1|
Primary Objective: To determine the feasibility of patients completing stereotactic body radiation therapy and at least one (1) cycle of Pembrolizumab.
- 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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab in Patients With High-Grade Epidural Disease|
|Actual Study Start Date :||March 28, 2022|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: Stereotactic Body Radiotherapy and Pembrolizumab Treatment
MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab
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.
Radiation: Stereotactic Body Radiation Therapy
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).
Other: Blood draws
Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy.
- Number of Participants Completing Stereotactic Body Radiation Therapy and One Cycle of Pembrolizumab [ Time Frame: 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.
- Change Thecal Sac Patency - (Percentage) [ Time Frame: 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.
- Accrual Rate [ Time Frame: Every 2 months, up to 20 months ]Number of enrolled per month on the study intervention.
- Number of Participants Experiencing Improvement in Pain - Numeric Pain Rating Scale (NPRS) [ Time Frame: 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) [ Time Frame: 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.
- Incidences of Compression Fractures [ Time Frame: 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 [ Time Frame: 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria :
- Pathologic diagnosis of cancer, confirmed by review of pathology report.
- Epidural disease seen on MRI at 1 vertebral level or 2 contiguous vertebral level.
- Synchronous and metachronous sites of disease allowed.
- Patient with expected life span of ≥ 3 months.
- Deemed eligible for stereotactic body radiation therapy and pembrolizumab after multi-disciplinary review. The multi-disciplinary review will be conducted virtually via our Spinal Oncology Group (SPOG) Wake Forest e-mail listserv. Members of the distribution list include neurosurgeons, orthopedic surgeons, interventional radiologists, radiologists, and radiation oncologists. This group meets monthly via Webex and in the interim, cases are routinely reviewed using encrypted emails via the listserv. Because we will not be able to wait for a month meeting to enroll patients on study, we anticipate needing to review these patients via the listserv. The electronic review will serve as documentation of multi-disciplinary review.
- Patients currently being treated with pembrolizumab or anticipated to receive at least one dose of pembrolizumab within six weeks after finishing stereotactic body radiation therapy.
- Patients who have received prior immunotherapy are allowed.
- Age equal or greater than 18.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05204290
|Contact: Study Coordinatorfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Baptist Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Study Coordinator 336-713-8457 email@example.com|
|Principal Investigator: Christina K Cramer, MD|
|Principal Investigator:||Christina K Cramer, MD||Wake Forest Baptist Health Sciences|
|Responsible Party:||Wake Forest University Health Sciences|
|Other Study ID Numbers:||
WFBCCC 03321 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
|First Posted:||January 24, 2022 Key Record Dates|
|Last Update Posted:||May 6, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Spinal Cord Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action