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Stereotactic Radiosurgery for Meningioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Kansas Hospital-Westwood Cancer Center, Westwood, KSMeningioma+4 MoreStereotactic Radiosurgery - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Grade II Meningioma
  • Grade III Meningioma
  • Grade 2 Meningioma
  • Grade 3 Meningioma
  • Recurrent Meningiomas

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Stereotactic Radiosurgery
1
Stereotactic Radiosurgery
1
Ipilimumab

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: At 6 months

At 6 months
Progression-free survival (PFS)
Day 100
Changes of peripheral T-cells
Up to 100 days
Deoxyribonucleic acid (DNA) sequencing
Incidence of adverse event profile (Phase I)
Maximum tolerated combination of radiosurgery and nivolumab plus or minus ipilimumab (Phase I)
Neoantigen signature
Objective radiological response (Phase II)
Objective response rate (ORR) (Phase II)
Overall survival (OS)
Ribonucleic acid (RNA) expression

Trial Safety

Safety Progress

1 of 3

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1
Stereotactic Radiosurgery
1
Stereotactic Radiosurgery
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Ipilimumab

Side Effects for

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

Trial Design

2 Treatment Groups

Cohort A (nivolumab, radiosurgery)
1 of 2
Cohort B (nivolumab, ipilimumab, radiosurgery)
1 of 2

Experimental Treatment

38 Total Participants · 2 Treatment Groups

Primary Treatment: Stereotactic Radiosurgery · No Placebo Group · Phase 1 & 2

Cohort A (nivolumab, radiosurgery)Experimental Group · 5 Interventions: Echocardiography, Biospecimen Collection, Magnetic Resonance Imaging, Nivolumab, Stereotactic Radiosurgery · Intervention Types: Procedure, Procedure, Procedure, Biological, Radiation
Cohort B (nivolumab, ipilimumab, radiosurgery)Experimental Group · 6 Interventions: Echocardiography, Biospecimen Collection, Magnetic Resonance Imaging, Ipilimumab, Nivolumab, Stereotactic Radiosurgery · Intervention Types: Procedure, Procedure, Procedure, Biological, Biological, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11830
Biospecimen Collection
2004
Completed Phase 1
~670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Ipilimumab
FDA approved
Nivolumab
FDA approved
Stereotactic Radiosurgery
2010
Completed Phase 2
~360

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 6 months

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,153 Previous Clinical Trials
41,162,295 Total Patients Enrolled
4 Trials studying Grade II Meningioma
286 Patients Enrolled for Grade II Meningioma
Jiayi HuangPrincipal InvestigatorYale University Cancer Center LAO

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have enough white blood cells in your body.
You must be able to perform your daily activities without assistance, or only need some help.
You are 18 years old or older.
You have a certain type of brain tumor called meningioma that has come back after radiation therapy and is getting worse based on imaging tests.
You have a brain lesion that can be measured and is between 1 and 5 centimeters in size, or has a volume less than 20 cubic centimeters. This lesion can be treated with reirradiation.
You must have had at least one surgery to remove your meningioma, and the doctor must have saved a small piece of the tumor tissue in a special way. If no tissue is available, 20-30 slides of the tissue can be used instead. The most recent sample of the tumor after the surgery should be submitted.
You have had radiation treatment before, but the total amount of radiation to the area where the cancer has returned cannot be more than 70 Gy. You must have waited at least 6 months since your previous radiation treatment to receive the study treatment.
Your blood test shows that you have enough infection-fighting white blood cells.
You have enough platelets in your blood, at least 100,000 per microliter.
The level of bilirubin in your body is not too high, and is within the normal range accepted by the study.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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