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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 70 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03530605
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Scott G. Turner
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Central Nervous System Neoplasms, Primary

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lifespan Physician Group, Neurosurgery, Providence, Rhode Island

Status

Not yet recruiting

Address

Lifespan Physician Group, Neurosurgery

Providence, Rhode Island, 02903

Site Contact

Steven Toms, MD

steven.toms@lifespan.org

401-793-9166

Saint Luke's Hospital of Kansas City, Kansas City, Missouri

Status

Address

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

The content provided by NBTS on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Terms, Conditions & Privacy