TERMINATED

Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab in Patients With High-Grade Epidural Disease

Quick Facts

Study Start:2022-03-28

Study Completion:2022-10-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05204290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Principal Investigator

Christina K Cramer, MD

PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Health Sciences

Study Locations (Sites)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Christina K Cramer, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-28

Study Completion Date2022-10-07

Study Record Updates

Study Start Date2022-03-28

Study Completion Date2022-10-07

Terms related to this study

Additional Relevant MeSH Terms

Epidural Spinal Tumors
Cancer