Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer

NCT03607682 | Terminated Results DMC FDA Device

• 2 other identifiers: VICC THO 1747NCI-2018-01428
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and/or reverse tumor growth by disrupting the way cancer cells grow.

Conditions

Extensive Stage Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Continuing Therapy Until Intracranial Tumor

  Count of patients developed intracranial tumor divided by total number of patients.

  Up to 6 months

Secondary Outcomes (8)

• Time to Intracranial Failure

  Up to 3 years

• Overall Survival

  Up to 3 years

• Rate of Intracranial Failure

  Up to 12 months

• Rate of Decline in Cognitive Function

  Up to 12 months

• Time to Neurocognitive Failure

  Up to 3 years

Study Arms (1)

Prevention (TTF therapy, NovoTTF-200A device)

EXPERIMENTAL

Procedure: Tumor Treating Fields (TTF) Therapy; Device: NovoTTF-200A Device; Other: Quality-of-Life Assessment

Interventions

Tumor Treating Fields (TTF) Therapy PROCEDURE

Undergo TTF therapy

Prevention (TTF therapy, NovoTTF-200A device)

NovoTTF-200A Device DEVICE

Undergo TTF therapy

Prevention (TTF therapy, NovoTTF-200A device)

Quality-of-Life Assessment OTHER

Ancillary studies

Prevention (TTF therapy, NovoTTF-200A device)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Life expectancy of \> 3 months
• Histologically proven extensive stage small cell lung carcinoma (ES-SCLC) (any T any N and any M stage) within 6 months prior to start of study treatment with the NovoTTF-200A, with a partial or complete response to at least four cycles of first-line chemotherapy
• Karnofsky performance status (KPS) \> 70
• Neutrophil count \> 1.5 x 10\^9/L
• Platelet count \> 100 x 10\^9/L
• Bilirubin \< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \< 2.5 x ULN or \< 5 x ULN if patient has documented liver metastases
• Serum creatinine \< 1.5 x ULN

You may not qualify if:

• Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast
• History of other prior malignancy within the past 5 years except for superficial skin cancers
• No severe comorbidities:
• History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)
• History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
• History of cerebrovascular accident (CVA) within 6 months prior to start of study treatment
• Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy
• History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
• Active implantable electronic medical devices in the brain; a skull defect, a shunt, or bullet fragments
• Known allergies to medical adhesives or hydrogel
• Unable to operate the NovoTTF-200A device independently or with the help of a caregiver
• If a female, currently pregnant, breastfeeding, or unwilling to avoid pregnancy while on study treatment
• Concurrent brain directed therapy (beyond NovoTTF-200A as per protocol)
• Prior clinical trial participation with brain directed therapy
• Concurrent treatment clinical trials

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• NovoCure Ltd.: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Therapeutics

Results Point of Contact

• Title: Teresa Melton
• Organization: Vanderbilt University Medical Center

teresa.melton@vumc.org

6159367423

Study Officials

• Albert Attia, MD

  Vanderbilt-Ingram Cancer Center

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 31, 2018
• Study Start: September 5, 2018
• Primary Completion: June 2, 2020
• Study Completion: July 13, 2020
• Last Updated: August 4, 2020
• Results First Posted: August 4, 2020

Record last verified: 2020-07

Locations

US (1)