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Virus Therapy

Laser Ablation + Radiosurgery for Spinal Cancer

N/A

Recruiting

Led By Ian Lee, MD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

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

Must have

ECOG performance status <2 or Karnofsky performance status (KPS) >50

Motor strength ≥4 out of 5 in extremity or extremities affected by the level of the spinal cord compression

Must not have

Unable to tolerate general anesthesia and prone position

Frank cord compression or cord compression from bone components or configuration and acute neurological deficits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, 9, 12, 18, and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat tumors near the spinal cord by combining two existing treatment methods. The goal is to improve tumor control and quality of life for patients with spinal metastasis.

Who is the study for?

This trial is for adults over 18 with inoperable spinal tumors from T2 to L1, not due to highly radiosensitive cancers like lymphoma. They must have a life expectancy over 3 months, agree to contraception if applicable, and be able to tolerate anesthesia and MRI scans. Participants should not be pregnant or have had recent radiation therapy on the same spine area.

What is being tested?

The study tests combining laser interstitial thermal ablation (LITA) with stereotactic spine radiosurgery (SSRS) for treating spinal metastases near the cord. It aims to see if this combo improves tumor control, pain relief, function preservation, and overall quality of life.

What are the potential side effects?

Potential side effects may include discomfort or complications from general anesthesia, heat damage to surrounding tissues during ablation, skin irritation or burns from radiosurgery, as well as typical risks associated with MRI-guided procedures.

Eligibility Criteria

Inclusion Criteria

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

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I can carry out all self-care but may not be able to do heavy physical work.

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I can move my arms or legs where my spine is compressed fairly well.

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The part of my spine needing treatment is between my upper back and mid-back.

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I am older than 18 years.

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My MRI shows I have a significant spinal cord compression.

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My spine cancer affects no more than 3 separate or connected areas.

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My cancer is a solid tumor and not highly sensitive to radiation.

Exclusion Criteria

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

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I cannot undergo surgery with general anesthesia or lie face down.

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I have spinal cord compression causing sudden nerve problems.

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I cannot lie flat for more than an hour.

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My cancer type is known to respond well to radiation therapy.

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I need a surgery on my spine without using cameras or screens for guidance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 6, 9, 12, 18, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 6, 9, 12, 18, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 9, 12, 18, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Local Tumor Control Rate

Secondary study objectives

Adverse Events

Neurologic Examination

Changes in symptoms assessed by physical examination

+3 more

Other study objectives

Measuring Quality of life (QOL) assessed by Brief Pain Inventory Survey (BPI)

Measuring Quality of life (QOL) assessed by Health Survey (SF-36)

Measuring Quality of life (QOL) assessed by Spine Tumor Survey (MDASI-SP)

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

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic RadiosurgeryExperimental Treatment3 Interventions

Patients will undergo laser interstitial thermal ablation and CT guided stereotactic radiosurgery via intensity-modulated radiation therapy on different dates within a one to fourteen day window. The order of treatment is at the treating physicians discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

0 / 12Eligibility criteria met