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

Extensive Stage Small Cell Lung Carcinoma Clinical Trial

Official title:

A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03607682
• Other study ID #: VICC THO 1747
• Secondary ID: NCI-2018-01428
• Status: Terminated
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: July 13, 2020

Study information

• Verified date: July 2020
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 13, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Carcinoma
• Small Cell Lung Carcinoma

Intervention

Procedure:
• Tumor Treating Fields (TTF) Therapy
Undergo TTF therapy

Device:
• NovoTTF-200A Device
Undergo TTF therapy

Other:
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	NovoCure Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Intracranial Failure	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.	Up to 3 years
Secondary	Overall Survival	Estimated using the Kaplan-Meier method.	Up to 3 years
Secondary	Rate of Intracranial Failure	Estimated using the cumulative incidence function	Up to 12 months
Secondary	Rate of Decline in Cognitive Function	Measured by Hopkins Verbal Language Test	Up to 12 months
Secondary	Time to Neurocognitive Failure	Measured by Hopkins Verbal Language Test	Up to 3 years
Secondary	Neurocognitive Failure-free Survival	Measured by Hopkins Verbal Language Test	Up to 3 years
Secondary	Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30	Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)	Up to 3 years
Secondary	Incidence of Adverse Events	Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	Up to 12 months