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

NCT03530605 | Withdrawn FDA Device

• 1 other identifier: Optune TTF in PCNSL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Central Nervous System Neoplasms, Primary

Keywords

PCNSL, primary central nervous system lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival Time

  Overall survival time

  4 years

Secondary Outcomes (4)

• Progression-Free Survival Time

  2 years

• One-Year Survival Rate

  1 year

• Radiographic Response Rate

  2 years

• Steroid & Antiepileptic Use

  2 years

Study Arms (2)

Optune TTF Device

EXPERIMENTAL

Optune TTF treatment

Device: Optune TTF device

Historical matched control

NO INTERVENTION

age-matched historical controls

Interventions

Optune TTF device DEVICE

portable device which produces electrical fields

Optune TTF Device

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Luke's Health System: lead
• NovoCure Ltd.: collaborator

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective group (non-randomized) compared to historical matched controls

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: August 31, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08