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Checkpoint Inhibitor

Stereotactic Radiosurgery for Meningioma

Phase 1 & 2
Recruiting
Led By Jiayi Huang
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights

Study Summary

This trial is testing nivolumab with or without ipilimumab as a treatment for recurrent meningioma. Nivolumab is an immunotherapy drug that may help the body's immune system attack the cancer. Ipilimumab is also an immunotherapy drug. Stereotactic radiosurgery is a type of radiation therapy.

Who is the study for?
Adults with Grade II-III meningioma that has returned after radiation therapy can join this trial. They must have a certain level of blood cells, normal organ function, and agree to use contraception if applicable. Pregnant or breastfeeding women, those on other trials, recent chemotherapy patients, individuals with severe allergies to similar drugs or active autoimmune diseases are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safe dosage of nivolumab combined with stereotactic radiosurgery for recurrent brain tumors (meningiomas), comparing results when used alone or alongside ipilimumab. These medications may help the immune system fight cancer by stopping tumor growth.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs like the liver or intestines, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, and infusion-related reactions such as fever or chills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 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
Incidence of adverse event profile (Phase I)
Maximum tolerated combination of radiosurgery and nivolumab plus or minus ipilimumab (Phase I)
Objective radiological response (Phase II)
+1 more
Secondary outcome measures
Changes of peripheral T-cells
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Deoxyribonucleic acid (DNA) sequencing
Neoantigen signature
Ribonucleic acid (RNA) expression

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702
32%
Fatigue
28%
Lymphocyte count decreased
24%
Cough
20%
Back pain
20%
Rash acneiform
16%
Anorexia
16%
Dry skin
16%
Hyperglycemia
16%
Rash maculo-papular
12%
Aspartate aminotransferase increased
12%
Non-cardiac chest pain
12%
Diarrhea
12%
Dyspepsia
12%
Headache
12%
Nausea
12%
Pain
12%
Pain in extremity
8%
Weight loss
8%
Wheezing
8%
Urinary tract pain
8%
Watering eyes
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Myalgia
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Skin infection
4%
Urinary tract infection
4%
White blood cell decreased
4%
Vomiting
4%
Sore throat
4%
Upper respiratory infection
4%
Urinary urgency
4%
Ear pain
4%
Oral hemorrhage
4%
Conjunctivitis
4%
Alkaline phosphatase increased
4%
Blood bilirubin increased
4%
Bone pain
4%
Bruising
4%
Depression
4%
Dry eye
4%
Dysgeusia
4%
Dysphagia
4%
Edema face
4%
Epistaxis
4%
Flashing lights
4%
Flu like symptoms
4%
Gastroesophageal reflux disease
4%
Hot flashes
4%
Hyperkalemia
4%
Hypernatremia
4%
Infusion site extravasation
4%
Insomnia
4%
Lethargy
4%
Nail loss
4%
Nail ridging
4%
Neck pain
4%
Neutrophil count decreased
4%
Papulopustular rash
4%
Platelet count decreased
4%
Pneumonitis
4%
Fracture
4%
Fall
4%
Skin hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Radiosurgery Followed by Erlotinib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B (nivolumab, ipilimumab, radiosurgery)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 30 minutes every 2 weeks for 12 doses (6 months) and then every 4 weeks for additional 6 months. Patients also receive ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 6 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients undergo multi-fraction stereotactic radiosurgery on days 1, 3, and 5. Patients undergo brain MRI and blood sample collection throughout the study. Patients may also undergo ECHO as clinically indicated.
Group II: Cohort A (nivolumab, radiosurgery)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo multi-fraction stereotactic radiosurgery on days 1, 3, and 5. Patients undergo brain MRI and blood sample collection throughout the study. Patients may also undergo ECHO as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Biospecimen Collection
2004
Completed Phase 2
~1920
Echocardiography
2013
Completed Phase 4
~11670
Ipilimumab
2014
Completed Phase 3
~2670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,357 Total Patients Enrolled
45 Trials studying Meningioma
4,199 Patients Enrolled for Meningioma
Jiayi HuangPrincipal InvestigatorYale University Cancer Center LAO

Frequently Asked Questions

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

To what extent has Stereotactic Radiosurgery been explored in other research studies?

"At the present moment, 765 clinical trials for Stereotactic Radiosurgery are underway. Of those active studies, 86 have reached Phase 3 of clinical research. Despite Pittsburgh being a primary hub for this study, 42755 sites across the globe are offering access to these treatments."

Answered by AI

To what extent has this research been implemented within U.S. medical practices?

"This trial is currently recruiting from 14 sites scattered throughout United States, including Miami, Los Angeles and Westwood. To reduce strain on the patient's time and budget, we encourage enrollees to choose a location close by their residence."

Answered by AI

To what maladies has Stereotactic Radiosurgery proven most efficacious?

"Stereotactic Radiosurgery is traditionally used for the treatment of anti-angiogenic therapy, but can also be beneficial for patients with malignant neoplasms, unresectable melanoma and squamous cell carcinoma."

Answered by AI

How many participants are involved in this research endeavor?

"For this medical study, 15 participants who meet the conditions of eligibility can take part. Those interested in enrolling have two options: The University of Miami Miller School of Medicine-Sylvester Cancer Center situated in Florida and USC / Norris Comprehensive Cancer Centre positioned in California."

Answered by AI

Are there any openings for participants in this clinical investigation?

"According to the clinicaltrials.gov website, this research trial is actively recruiting patients. The initial posting was done on November 21st 2018 and has been recently updated as of November 15th 2022."

Answered by AI
~5 spots leftby Dec 2024