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Pre-Surgical Radiosurgery for Brain Metastases

Phase < 1

Recruiting

Led By Zachary Buchwald, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Patients must have adequate organ function as determined by Neurosurgery to undergo surgery

Must not have

Patients on any immunosuppressive medication other than dexamethasone

Prior whole brain radiotherapy or SRS to the same site planned for surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

This trial is to see if there are side effects from giving stereotactic radiosurgery to patients with brain metastases before surgery. Radiation may stimulate an anti-tumor immune response.

Who is the study for?

This trial is for adults over 18 with cancer that has spread to the brain, visible on MRI. They must have a life expectancy of more than 12 weeks, be able to undergo surgery, and follow study procedures. Pregnant or nursing women, those on immunosuppressants (except dexamethasone), or with certain serious illnesses can't participate.

What is being tested?

The trial tests if stereotactic radiosurgery before surgery can prevent cancer from returning in patients with brain metastases. It's an early phase I trial focused on understanding side effects and how well this pre-surgery radiation works as a treatment.

What are the potential side effects?

Potential side effects may include typical reactions to radiation like headaches, nausea, fatigue, hair loss at the treatment site, and skin irritation. Surgery risks include bleeding, infection, and reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My doctor says my body is strong enough for surgery.

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I am 18 years old or older.

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I have or might have had cancer before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking immunosuppressive medication, but not dexamethasone.

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I have had brain radiation or surgery at the same spot that is now planned for surgery.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events grade 3 or greater

Secondary study objectives

Density of immune niche in brain metastases

Overall survival (OS)

Time to anywhere brain failure (ABF)

+1 more

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

Urinary tract pain

Watering eyes

Weight loss

Myalgia

Wheezing

Arthralgia

Edema limbs

Abdominal pain

Paronychia

Pruritus

Blurred vision

Skin and subcutaneous tissue disorders - Other, specify

Upper respiratory infection

Vomiting

Urinary tract infection

White blood cell decreased

Lethargy

Sore throat

Skin infection

Urinary urgency

Insomnia

Infusion site extravasation

Ear pain

Oral hemorrhage

Conjunctivitis

Alkaline phosphatase increased

Blood bilirubin increased

Bone pain

Bruising

Depression

Dry eye

Dysgeusia

Dysphagia

Edema face

Epistaxis

Flashing lights

Flu like symptoms

Gastroesophageal reflux disease

Hot flashes

Hyperkalemia

Hypernatremia

Nail loss

Nail ridging

Neck pain

Neutrophil count decreased

Papulopustular rash

Platelet count decreased

Pneumonitis

Fracture

Fall

Skin hyperpigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Radiosurgery Followed by Erlotinib

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (SRS, high dose dexamethasone, surgery)Experimental Treatment2 Interventions

Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.

Group II: Arm A (SRS, low dose dexamethasone, surgery)Experimental Treatment3 Interventions

Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

Resection

2020

Completed Phase 2

~1440

Stereotactic Radiosurgery

2021