Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab

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.

Conditions

Epidural Spinal Tumors, Cancer

Study Overview

Study Details

Study overview

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.

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

Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab

Condition
Epidural Spinal Tumors
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States, 27157

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

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

Study Record Dates

2024-12