Clinical trial NCT03530605: Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma
Official title: Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Central Nervous System Neoplasms, Primary
Keywords: PCNSL, primary central nervous system lymphoma
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: NovoCure Ltd.
First posted: 2018-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective group (non-randomized) compared to historical matched controls
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival Time
timeFrame: 4 years
Secondary outcomes:
measure: Progression-Free Survival Time
timeFrame: 2 years
measure: One-Year Survival Rate
timeFrame: 1 year
measure: Radiographic Response Rate
timeFrame: 2 years
measure: Steroid & Antiepileptic Use
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
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