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

• Sponsor: Vanderbilt-Ingram Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03607682
• Collaborator: NovoCure Ltd. (Industry)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.2
• Patients Per Site Per Month: 0.1

Study Details

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	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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:

1. 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.

2. 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.

3. 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.

4. 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
• 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: Sep 5, 2018
• Actual Primary Completion Date: Jun 2, 2020
• Actual Study Completion Date: Jul 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 [Up to 6 months]

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

Secondary Outcome Measures

1. 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.

2. Overall Survival [Up to 3 years]

   Estimated using the Kaplan-Meier method.

3. Rate of Intracranial Failure [Up to 12 months]

   Estimated using the cumulative incidence function

4. Rate of Decline in Cognitive Function [Up to 12 months]

   Measured by Hopkins Verbal Language Test

5. Time to Neurocognitive Failure [Up to 3 years]

   Measured by Hopkins Verbal Language Test

6. Neurocognitive Failure-free Survival [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 [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 [Up to 12 months]

   Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - Feb 6, 2019

More Information

Publications

None provided.

• Responsible Party: Wade Iams, Principal Investigator, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT03607682
• Other Study ID Numbers: VICC THO 1747; NCI-2018-01428
• First Posted: Jul 31, 2018
• Last Update Posted: Aug 4, 2020
• Last Verified: Jul 1, 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

Study Results

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 Detail	2 participants were enrolled; 1 participant had disease progression and was not on the study long enough to be evaluable.

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 50%
>=65 years	1 50%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	2 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 50%
White	1 50%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

patients on the therapy

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	2
Count of Participants [Participants]	1 50%

2. Secondary Outcome

Title	Time to Intracranial Failure
Description	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

Outcome Measure Data

Analysis Population Description

Data was not collected do to loss of funding.

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

3. Secondary Outcome

Title	Overall Survival
Description	Estimated using the Kaplan-Meier method.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Data was not collected do to loss of funding.

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

4. Secondary Outcome

Title	Rate of Intracranial Failure
Description	Estimated using the cumulative incidence function
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Data was not collected do to loss of funding.

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

5. Secondary Outcome

Title	Rate of Decline in Cognitive Function
Description	Measured by Hopkins Verbal Language Test
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Data was not collected do to loss of funding.

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

6. Secondary Outcome

Title	Time to Neurocognitive Failure
Description	Measured by Hopkins Verbal Language Test
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Data was not collected do to loss of funding.

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

7. Secondary Outcome

Title	Neurocognitive Failure-free Survival
Description	Measured by Hopkins Verbal Language Test
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Data was not collected do to loss of funding.

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

8. Secondary Outcome

Title	Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Description	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

Outcome Measure Data

Analysis Population Description

Data was not collected do to loss of funding.

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

9. Secondary Outcome

Title	Incidence of Adverse Events
Description	Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Patients on the therapy

Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
Measure Participants	2
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	The adverse event reporting period began immediately following registration to treatment (start of use of the NovoTTF-200A device). Adverse events were collected for 8 weeks following treatment termination.
Arm/Group Title	Prevention (TTF Therapy, NovoTTF-200A Device)
Arm/Group Description	Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy NovoTTF-200A Device: Undergo TTF therapy Quality-of-Life Assessment: Ancillary studies
All Cause Mortality
	Prevention (TTF Therapy, NovoTTF-200A Device)
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Prevention (TTF Therapy, NovoTTF-200A Device)
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Prevention (TTF Therapy, NovoTTF-200A Device)
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.