Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma

This study will compare the overall survival (OS) time of elderly patients who would not tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those treated with whole-brain radiotherapy alone.

Standard treatment of primary central nervous system lymphoma (PCNSL) for patients with good performance status involves high-dose methotrexate-based chemotherapy regimens and whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years of age or older, little data exist with regard to optimal treatment of this patient population and they often do not qualify for clinical trials. In addition, elderly patients have a poorer rate of complete and partial response and increased risk of toxicity when treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy alone is often used in these patients to minimize toxic effects of more aggressive chemotherapies.

The Optune TTF device has proven effective in treating high-grade gliomas and is currently being investigated to treat meningiomas and metastatic lesions in the brain as well as other tumor types elsewhere in the body. It is generally well tolerated with no known systemic side effects, producing only an occasional local skin reaction. The mechanism of action is independent of tumor type and therefore may be effective in treating lymphoma as well.

Study Overview

• Status: Withdrawn
• Conditions: Central Nervous System Neoplasms, Primary
• Intervention / Treatment: Device: Optune TTF device

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histological de novo diagnosis of PCNSL
• Tumor located in the supra-tentorial brain region
• Karnofsky performance score of 70 or above
• Ineligible for chemotherapy due to age or other co-morbidities
• Life expectancy of at least 3 months
• Patient has a caretaker willing to assist with study compliance
• Patient is able to provide written consent on their own behalf

Exclusion Criteria:

• Second or subsequent recurrence of PCNSL
• Patient wishes to receive systemic treatment
• Implanted electronic medical device in the brain (deep brain stimulator, vagus nerve stimulator, programmable shunt, etc.)
• Skull defect without replacement
• Prior radiation, surgery, or chemotherapy for PCNSL within the 4 weeks prior to enrollment
• Patient unable to comply with Optune device treatment or the study follow- up schedule
• Active participation in another therapeutic clinical trial
• Patient unable to provide written consent on their own behalf

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optune TTF Device; Optune TTF treatment	Device: Optune TTF device; portable device which produces electrical fields
No Intervention: Historical matched control; age-matched historical controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time	Overall survival time	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival Time	Progression-free survival time	2 years
One-Year Survival Rate	One-year survival rate	1 year
Radiographic Response Rate	Tumor response by MRI measurement	2 years
Steroid & Antiepileptic Use	use of concomitant steroids and antiepileptic use	2 years

Collaborators and Investigators

• Sponsor: Saint Luke's Health System
• Collaborators: NovoCure Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2020
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: PCNSL, primary central nervous system lymphoma
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms by Site; Lymphoma; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: Optune TTF in PCNSL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes