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Monoclonal Antibodies
Stereotactic Radiosurgery + Immunotherapy for Meningioma
Phase 2
Recruiting
Led By Nancy Oberheim Bush, MD, PhD
Research Sponsored by Nancy Ann Oberheim Bush, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be >= 18 years of age on day of signing informed consent
Participants must be at least 4 weeks (or 5 half-lives, whichever is shorter) from other prior cytotoxic chemotherapy (6 weeks from nitrosoureas) or biologic therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing if a single dose of radiation therapy, given with the help of special equipment to target the tumor precisely, and a laboratory-made protein that blocks the PD-1 receptor, may improve progression-free survival for patients with meningioma that has come back.
Who is the study for?
Adults with recurrent grade II or III meningioma, previously treated with surgery and radiotherapy. Participants must be in good health otherwise, not pregnant or breastfeeding, willing to use contraception, and have no other active cancers or severe psychiatric issues. They should not have had recent immunosuppressive treatments or live vaccines.Check my eligibility
What is being tested?
The trial is testing the combination of stereotactic radiosurgery (precise radiation therapy) and pembrolizumab (an immune system-boosting drug) to see if it can improve survival without cancer growth in patients with recurring brain tumors called meningiomas.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, infusion reactions, fatigue, skin rash, hormone gland problems like thyroid disorders, and could worsen pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I haven't had chemotherapy or biologic therapy for at least 4 weeks.
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I had an MRI within the last 28 days and have been on a low, stable dose of steroids.
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My meningioma is grade II or III, has grown or returned after surgery and radiation.
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I am eligible for radiation therapy with specific volume limits based on the number of sessions.
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My kidney function, measured by creatinine or GFR, is within the required range.
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I am able to care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with Progression Free Survival at 12 months (PFS12)
Secondary outcome measures
Median overall survival (OS)
Median progression free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment for recurrent meningioma (pembrolizumab, stereotactic radiosurgery)Experimental Treatment2 Interventions
Participants with recurrent grade II or III meningioma will receive stereotactic radiosurgery. in conjunction with pembrolizumab 200mg IV infusion on day 1 (to -1) of radiation and then every 3 weeks. Participants may be eligible for up to 17 additional cycles of pembrolizumab depending on disease status after completion of first course.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
Nancy Ann Oberheim Bush, MDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,109 Total Patients Enrolled
1 Trials studying Meningioma
26 Patients Enrolled for Meningioma
Nancy Oberheim Bush, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on high-dose steroids or other drugs that weaken my immune system.It's been over 28 days since my surgery and I've fully recovered without any ongoing health issues.I have had pneumonitis treated with steroids or currently have it.I agree to use birth control and not donate sperm for 120 days after my last treatment dose.You had a stereotactic biopsy more than 7 days ago.I have not had active treatment for another cancer, except for certain skin cancers or localized cancers, in the last 3 years.I haven't been on another clinical trial for at least 4 weeks.I am 18 years old or older.I haven't had chemotherapy or biologic therapy for at least 4 weeks.I had an MRI within the last 28 days and have been on a low, stable dose of steroids.I have a known history of HIV.You need to have specific blood tests done within the last 28 days to check your overall health. These tests include checking your albumin, alkaline phosphatase, calcium, bilirubin, urea nitrogen, creatinine, protein, glucose, potassium, sodium, chloride, bicarbonate, magnesium, and phosphorus levels.I have a history of hepatitis B or active hepatitis C.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am not pregnant or breastfeeding and will follow birth control advice for 4 months after treatment.I have not received a live vaccine in the last 30 days.I have been treated with specific immune therapy drugs before.My meningioma is grade II or III, has grown or returned after surgery and radiation.I have an active TB infection.I am eligible for radiation therapy with specific volume limits based on the number of sessions.You have enough infection-fighting white blood cells in your body.Your platelet count is at least 100,000 per microliter within the last 28 days before joining the study.My kidney function, measured by creatinine or GFR, is within the required range.My blood clotting time is normal or managed if I'm on blood thinners.Your bilirubin levels should be within a certain range, or you may not be able to join the study.Your AST and ALT levels should be no more than 2.5 times the upper limit of normal.Your hemoglobin level is at least 9.0 g/dL within the last 28 days.I am currently being treated for an infection.I haven't had any radiotherapy in the last 6 months, unless it was outside the treatment area, then within the last 2 weeks.I have had multiple surgeries or treatments for my condition.My tumor is in the brainstem or spinal cord but isn't growing.I haven't taken immunosuppressive drugs like methotrexate in the last 3 months.My blood clotting time is normal or managed with medication.My MRI shows bleeding in or around my tumor, but it's minor or stable.My cancer has spread outside the brain and spinal cord.I have recovered from major side effects of my previous treatment, except for hair loss.I am able to care for myself but may not be able to do active work.You have had a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment for recurrent meningioma (pembrolizumab, stereotactic radiosurgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what medical ailments does Pembrolizumab prove to be efficacious?
"Pembrolizumab is typically prescribed for malignant tumours. It can also be utilized to alleviate unresectable melanoma, microsatellite instability high conditions and chemotherapeutic resistance."
Answered by AI
Could you please explain what prior research has been conducted in relation to Pembrolizumab?
"Currently, a total of 961 clinical trials are evaluating Pembrolizumab. Out of these ongoing studies, 122 have progressed to the third phase. Though Houston, Texas serves as its epicentre with 35731 medical sites conducting research on this treatment."
Answered by AI
How many participants are partaking in this clinical experiment?
"Affirmative. Clinicaltrials.gov attests that this research is currently recruiting individuals, having been first posted on March 25th 2021 and adjusted most recently on October 28th 2022. The investigators need to recruit 90 patients from one medical centre."
Answered by AI
Has the FDA sanctioned Pembrolizumab as a treatment option?
"Due to the Phase 2 status of Pembrolizumab, our team at Power has assessed its safety rating as a 2, given that there is some evidence for safety but no data yet in regards to efficacy."
Answered by AI
Is enrollment for this medical study still open?
"According to the clinicaltrials.gov entry, this medical research is still looking for volunteers. It was created on March 25th 2021 and last edited October 28th 2022."
Answered by AI
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