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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03530605
Recruitment Status : Withdrawn (Study never initiated, PI left institution)
First Posted : May 21, 2018
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Saint Luke's Health System

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.


Condition or disease Intervention/treatment Phase
Central Nervous System Neoplasms, Primary Device: Optune TTF device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective group (non-randomized) compared to historical matched controls
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma
Estimated Study Start Date : August 31, 2020
Estimated Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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



Primary Outcome Measures :
  1. Overall Survival Time [ Time Frame: 4 years ]
    Overall survival time


Secondary Outcome Measures :
  1. Progression-Free Survival Time [ Time Frame: 2 years ]
    Progression-free survival time

  2. One-Year Survival Rate [ Time Frame: 1 year ]
    One-year survival rate

  3. Radiographic Response Rate [ Time Frame: 2 years ]
    Tumor response by MRI measurement

  4. Steroid & Antiepileptic Use [ Time Frame: 2 years ]
    use of concomitant steroids and antiepileptic use



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT03530605    
Other Study ID Numbers: Optune TTF in PCNSL
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Saint Luke's Health System:
PCNSL, primary central nervous system lymphoma
Additional relevant MeSH terms:
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Lymphoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases