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Monoclonal Antibodies

Pembrolizumab + Spine Radiosurgery for Spinal Tumors

Phase < 1
Recruiting
Led By Christina K Cramer, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologic diagnosis of cancer, confirmed by review of pathology report
Epidural disease seen on MRI at 1 vertebral level or 2 contiguous vertebral levels
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months, up to 20 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment, Pembrolizumab, in combination with radiosurgery for people with high-grade epidural disease of the spine.

Who is the study for?
This trial is for adults over 18 with a confirmed cancer diagnosis affecting the spine, who have an expected lifespan of at least 3 months. They should be eligible for radiation therapy and pembrolizumab treatment, and may already be on or scheduled to start pembrolizumab soon. Excluded are those with contraindications to pembrolizumab, other ongoing trials, symptomatic brain metastases that affect neurological assessments, severe illnesses or conditions that could interfere with the study, pregnant women, prior treatments to the lesion area, certain types of tumors like lymphoma or multiple myeloma.Check my eligibility
What is being tested?
The study investigates the combined effect of Stereotactic Body Radiation Therapy (a precise high-dose radiation treatment) and Pembrolizumab (an immunotherapy drug) on patients with advanced spinal cancer. The goal is to assess how well these treatments work together in controlling disease progression in the spine.See study design
What are the potential side effects?
Pembrolizumab can cause immune system-related side effects such as inflammation in various organs including lungs and intestines; skin reactions; hormone gland problems; infusion-related reactions; fatigue; liver issues. Radiation therapy might lead to localized skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer diagnosis has been confirmed by a pathology report.
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My MRI shows epidural disease at 1 or 2 connected spine levels.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months, up to 20 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months, up to 20 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Completing Stereotactic Body Radiation Therapy and One Cycle of Pembrolizumab
Secondary outcome measures
Accrual Rate
Change Thecal Sac Patency - (Percentage)
Plasma Exchange
+3 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
79%
Cough
64%
Nausea
64%
Dyspnea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anorexia
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Dysphagia
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Hemorrhoids
7%
Amnesia
7%
Dehydration
7%
Dysuria
7%
Hypertension
7%
Creatinine increased
7%
Dysgeusia
7%
Confusion
7%
Dementia
7%
Hypernatremia
7%
Productive cough
7%
Pneumonitis
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Blurred vision
7%
Hearing impaired
7%
Rash
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Sinusitis
7%
Alopecia
7%
Esophagitis
7%
Otitis externa
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic Body Radiotherapy and Pembrolizumab TreatmentExperimental Treatment3 Interventions
MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,001,986 Total Patients Enrolled
Christina K Cramer, MDPrincipal InvestigatorWake Forest Baptist Health Sciences
1 Previous Clinical Trials
244 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this research project?

"Affirmative. According to information published on clinicaltrials.gov, this medical trial is still seeking applicants and was first posted online on March 28th 2022. The study requires 10 participants from a single testing centre as of May 11th 2022."

Answered by AI

Is there currently an opportunity for people to join the research project?

"The trial is still open to patients, as noted on clinicaltrials.gov. This research was initially posted on March 28th 2022 and last revised on May 11th of the same year."

Answered by AI
~2 spots leftby Sep 2024