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

• ClinicalTrials.gov Identifier: NCT03607682
• Recruitment Status: Terminated
• First Posted: July 31, 2018
• Results First Posted: August 4, 2020
• Last Update Posted: August 4, 2020
• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: NovoCure Ltd.
• Information provided by (Responsible Party): Wade Iams, Vanderbilt-Ingram Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Extensive Stage Small Cell Lung Carcinoma	Procedure: Tumor Treating Fields (TTF) Therapy; Device: NovoTTF-200A Device; Other: Quality-of-Life Assessment	Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months.

SECONDARY OBJECTIVES:

I. To evaluate time to intracranial failure after NovoTTF-200A. II. To evaluate overall survival after NovoTTF-200A. III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.

IV. To evaluate intracranial failure free survival after NovoTTF-200A. V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.

VI. To evaluate time to neurocognitive failure after NovoTTF-200A. VII. To evaluate neurocognitive failure-free survival after NovoTTF-200A. VIII. To evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC Quality of life Questionnaire C30) with BN20 addendum after NovoTTF-200A.

IX. To assess adverse events, severity, and frequency associated with NovoTTF-200A using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

OUTLINE:

Participants undergo tumor-treating fields therapy using the NovoTTF-200A device over 18 hours per day for a minimum of 4 weeks and up to 1 year in the absence of disease progression, unacceptable toxicity, or intracranial failure.

After completion of study treatment, participants are followed up at 8 weeks.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer
• Actual Study Start Date: September 5, 2018
• Actual Primary Completion Date: June 2, 2020
• Actual Study Completion Date: July 13, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Prevention (TTF therapy, NovoTTF-200A device)	Procedure: Tumor Treating Fields (TTF) Therapy; Undergo TTF therapy; Device: NovoTTF-200A Device; Undergo TTF therapy; Other: Quality-of-Life Assessment; Ancillary studies

Outcome Measures

Primary Outcome Measures :

1. Percentage of Patients Continuing Therapy Until Intracranial Tumor [ Time Frame: Up to 6 months ]
   Count of patients developed intracranial tumor divided by total number of patients.

Secondary Outcome Measures :

1. Time to Intracranial Failure [ Time Frame: Up to 3 years ]
   Time to intracranial failure with death as a competing risk will be estimated using cumulative incidence function (CIF) and reported with a one-sided 95% confidence interval.
2. Overall Survival [ Time Frame: Up to 3 years ]
   Estimated using the Kaplan-Meier method.
3. Rate of Intracranial Failure [ Time Frame: Up to 12 months ]
   Estimated using the cumulative incidence function
4. Rate of Decline in Cognitive Function [ Time Frame: Up to 12 months ]
   Measured by Hopkins Verbal Language Test
5. Time to Neurocognitive Failure [ Time Frame: Up to 3 years ]
   Measured by Hopkins Verbal Language Test
6. Neurocognitive Failure-free Survival [ Time Frame: Up to 3 years ]
   Measured by Hopkins Verbal Language Test
7. Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [ Time Frame: Up to 3 years ]
   Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)
8. Incidence of Adverse Events [ Time Frame: Up to 12 months ]
   Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

NovoCure Ltd.

Investigators

• Principal Investigator: Albert Attia, MD; Vanderbilt-Ingram Cancer Center

  Study Documents (Full-Text)

Documents provided by Wade Iams, Vanderbilt-Ingram Cancer Center:

Study Protocol and Statistical Analysis Plan  [PDF] February 6, 2019

More Information

• Responsible Party: Wade Iams, Principal Investigator, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT03607682
• Other Study ID Numbers: VICC THO 1747; NCI-2018-01428 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
• First Posted: July 31, 2018
• Results First Posted: August 4, 2020
• Last Update Posted: August 4, 2020
• Last Verified: July 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Small Cell Lung Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases