Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain

NCT03488472 | Terminated Results DMC FDA Device

• 1 other identifier: IRB-300001201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC).

Conditions

Brain Metastases; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Distant Metastases

  Rate of distant CNS metastases/progression will be calculated as the total number of patients with such events divided by the total number of patients.

  From date of first SRS treatment to time of the 6 month follow-up MRI

Secondary Outcomes (3)

• Overall Survival

  From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.

• Local Recurrence

  From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.

• Distant CNS Progression

  From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.

Study Arms (1)

NovoTTF-200A device + Stereotactic Radiosurgery (SRS)

EXPERIMENTAL

Patients will undergo SRS treatment followed by continuous TTFields by wearing the NovoTTF-200A device over 18 hours QD. Treatment continues for up to 1 year or until progression.

Device: NovoTTF-200A; Radiation: Stereotactic Radiosurgery (SRS)

Interventions

NovoTTF-200A DEVICE

Begins within 7 days of SRS and continues until progression, death, or unacceptable toxicity.

NovoTTF-200A device + Stereotactic Radiosurgery (SRS)

Stereotactic Radiosurgery (SRS) RADIATION

SRS will begin within 21 days of study enrollment for 5-6 Gy per fraction for a total of 25 or 30 Gy.

NovoTTF-200A device + Stereotactic Radiosurgery (SRS)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must have history of histologically confirmed small cell lung cancer. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
• Brain metastases that have not received radiotherapy previously (metastases on post-contrast MRI obtained within six weeks of study entry) deemed to be amenable to SRS.
• Longest diameter \< 4 cm
• Prior prophylactic cranial irradiation (PCI) is allowed. The maximum allowed dose is 25Gy in 10 fractions.
• Prior systemic therapy is allowed after diagnosis of brain metastases provided that restaging MRI shows measurable intracranial disease.
• Karnofsky Performance Status (KPS) of greater than or equal to 70.
• Age greater than or equal to 18 years.
• Life expectancy greater than 3 months.
• Must receive optimal therapy for extracranial disease and may continue on systemic therapy during TTF administration.
• Ability to operate the NovoTTF-200A device independently or with caregiver aid.
• Previous clinical trial enrollment is allowed.
• Subjects given written informed consent.

You may not qualify if:

• History of prior brain metastases.
• Patients with significant edema leading to risk of brain herniation.
• History of prior whole brain radiotherapy (WBRT) other than prophylactic cranial radiation. Prophylactic cranial radiation with a maximum dose of 25 Gy delivered as 10 fractions is allowed. WBRT in excess of 25 Gy (anything over 25 Gy) is not allowed.
• Diffuse Leptomeningeal metastases with radiographic involvement in the brain and/or spinal cord. This does not include local leptomeningeal involvement which is defined as leptomeningeal enhancement within direct contact of targetable metastases.
• Implantable electronic device in the brain.
• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
• Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness).
• Known allergies to medical adhesives or hydrogel.
• Currently pregnant or breastfeeding.
• Concurrent brain-directed therapy.
• Insufficient recovery from all active toxicities of prior therapies.
• Women of childbearing potential who are not using an effective method of contraception are excluded.

Sponsors & Collaborators

• Drexell Hunter Boggs: lead
• NovoCure Ltd.: collaborator

Study Sites (1)

University of Alabama at Birmingham (UAB), Hazelrig-Salter Radiation Oncology Center (HSROC)

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Small Cell Lung Carcinoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

The 1 patient enrolled started treatment but was discontinued due adrenal mets. Therefore, data not collected.

Results Point of Contact

• Title: Drexell Hunter Boggs, MD; Principal Investigator
• Organization: University of Alabama at Birmingham (UAB)

dboggs@uabmc.edu

(205) 934-3411

Study Officials

• Drexell H Boggs, MD

  University of Alabama at Birmingham (UAB)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 5, 2018
• Study Start: August 9, 2019
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: May 6, 2023
• Results First Posted: January 4, 2023

Record last verified: 2023-05

Locations

US (1)