Extensive Stage Small Cell Lung Carcinoma
Conditions
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.
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.
Interventions
PROCEDURETumor Treating Fields (TTF) Therapy
Undergo TTF therapy
DEVICENovoTTF-200A Device
Undergo TTF therapy
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
NovoCure Ltd.
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Continuing Therapy Until Intracranial Tumor | Up to 6 months | Count of patients developed intracranial tumor divided by total number of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 3 years | Estimated using the Kaplan-Meier method. |
| Rate of Intracranial Failure | Up to 12 months | Estimated using the cumulative incidence function |
| Rate of Decline in Cognitive Function | Up to 12 months | Measured by Hopkins Verbal Language Test |
| Time to Intracranial Failure | 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. |
| Neurocognitive Failure-free Survival | Up to 3 years | Measured by Hopkins Verbal Language Test |
| Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 | Up to 3 years | Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4) |
| Incidence of Adverse Events | Up to 12 months | Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 |
| Time to Neurocognitive Failure | Up to 3 years | Measured by Hopkins Verbal Language Test |
Countries
United States
Participant flow
Recruitment details
This trial was open to accrual from September 2018 to June 2020 at Vanderbilt Medical Center in Nashville, TN. Two participants were enrolled. The study stopped early due to loss of funding.
Pre-assignment details
2 participants were enrolled; 1 participant had disease progression and was not on the study long enough to be evaluable.
Participants by arm
| Arm | Count |
|---|---|
| Prevention (TTF Therapy, NovoTTF-200A Device) Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy
NovoTTF-200A Device: Undergo TTF therapy
Quality-of-Life Assessment: Ancillary studies | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease progression | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Prevention (TTF Therapy, NovoTTF-200A Device) |
|---|---|
| Age, Categorical Race <=18 years | 0 Participants |
| Age, Categorical Race >=65 years | 1 Participants |
| Age, Categorical Race Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Percentage of Patients Continuing Therapy Until Intracranial Tumor
Count of patients developed intracranial tumor divided by total number of patients.
Time frame: Up to 6 months
Population: patients on the therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevention (TTF Therapy, NovoTTF-200A Device) | Percentage of Patients Continuing Therapy Until Intracranial Tumor | 1 Participants |
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)
Time frame: Up to 3 years
Population: Data was not collected do to loss of funding.
Secondary
Incidence of Adverse Events
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 12 months
Population: Patients on the therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevention (TTF Therapy, NovoTTF-200A Device) | Incidence of Adverse Events | 0 Participants |
Secondary
Neurocognitive Failure-free Survival
Measured by Hopkins Verbal Language Test
Time frame: Up to 3 years
Population: Data was not collected do to loss of funding.
Secondary
Overall Survival
Estimated using the Kaplan-Meier method.
Time frame: Up to 3 years
Population: Data was not collected do to loss of funding.
Secondary
Rate of Decline in Cognitive Function
Measured by Hopkins Verbal Language Test
Time frame: Up to 12 months
Population: Data was not collected do to loss of funding.
Secondary
Rate of Intracranial Failure
Estimated using the cumulative incidence function
Time frame: Up to 12 months
Population: Data was not collected do to loss of funding.
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.
Time frame: Up to 3 years
Population: Data was not collected do to loss of funding.
Secondary
Time to Neurocognitive Failure
Measured by Hopkins Verbal Language Test
Time frame: Up to 3 years
Population: Data was not collected do to loss of funding.