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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 03321 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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Low accruals
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiotherapy and Pembrolizumab Treatment | Experimental | MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing Stereotactic Body Radiation Therapy (SBRT) 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. | At Day 5 and up to cycle 1 (Day 22) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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. |
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Inclusion Criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina K Cramer, MD | Wake Forest Baptist Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: 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. 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). Blood draws: Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: 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. 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). Blood draws: Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Completing Stereotactic Body Radiation Therapy (SBRT) 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. | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | At Day 5 and up to cycle 1 (Day 22) |
|
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: 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. 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). Blood draws: Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy. |
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The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina K. Cramer, MD | Wake Forest University Health Sciences | 336-713-3600 | Christina.Cramer@wfusm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2021 | Jun 2, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 27, 2024 | Aug 27, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015174 | Epidural Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D016634 | Radiosurgery |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Stereotactic Body Radiation Therapy | Radiation | 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). |
|
| Blood draws | Other | Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy. |
|
| At baseline, at 2 months and 6 months after intervention |
| Accrual Rate | Number of enrolled per month on the study intervention. | Every 2 months, up to 6 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. | At baseline, at 2 months and 6 months after intervention |
| 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. | At baseline, at 2 months and 6 months after intervention |
| 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 | 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 | At baseline, 2 months and 6 months after intervention |
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in 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. | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | At baseline, at 2 months and 6 months after intervention |
|
|
| Secondary | Accrual Rate | Number of enrolled per month on the study intervention. | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | Every 2 months, up to 6 months |
|
|
| Secondary | 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. | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | At baseline, at 2 months and 6 months after intervention |
|
|
| Secondary | 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. | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | At baseline, at 2 months and 6 months after intervention |
|
|
| Secondary | 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 | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | 1 month after intervention and 6 months after intervention |
|
|
| Secondary | 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 | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | At baseline, 2 months and 6 months after intervention |
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| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |