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

Status: Active

Description

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.

Eligibility 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 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 received 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

Locations & Contacts

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Albert Attia
Phone: 615-322-2555

Trial Objectives and Outline

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 QLQ 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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
Vanderbilt University / Ingram Cancer Center

Principal Investigator
Albert Attia

Trial IDs

Primary ID VICC THO 1747
Secondary IDs NCI-2018-01428
Clinicaltrials.gov ID NCT03607682