Neurotoxicity in Primary Central Nervous System Lymphoma (PCNSL): An International Observational Study of Cognition in Long Term Survivors

OHSU Knight Cancer Institute

Status: Terminated

Conditions: Primary Central Nervous System Lymphoma (PCNSL)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00710151

OHSU-3805 (Other Identifier)

IRB00003805

R01NS033618 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This research is being done to investigate cognition in long term survivors of Primary Central Nervous System Lymphoma (PCNSL). Sometimes caregivers as well as patients who no longer have the disease report cognitive problems such as reduced memory or attentional dysfunction and decreased quality of life. Unfortunately, little is known about what may contribute to this cognitive dysfunction in part because PCNSL is a rare disease and sensitive tests have not often been used in the research studies. This project is being conducted to help understand what factors, such as radiation, may contribute to cognitive dysfunction and better define the relationship between brain structure and thinking in people who have had PCNSL.

Full description

This is an international, multi-center project that will enroll as many as 118 subjects of which approximately 35 will be enrolled at Oregon Health & Science University (OHSU). Neuropsychological testing will consist of a battery of paper and pencil tests that examine abilities such as memory, motor skills, attention and speed of information processing. Questionnaires that assess quality of life will also be administered. These noninvasive tests are administered by a trained examiner or neuropsychologist and last about 30 minutes. Subjects will also undergo an MRI of the head which provides a picture of the brain's structure by placing an individual inside a powerful magnet. Statistical analyses will examine the relationship between the neuropsychological test scores and magnetic resonance (MR) images as well as examine the contribution of factors such as radiation, age, surgery, chemotherapy etc. to cognition.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Radiological and histological diagnosis of PCNSL
• Age 18 years or older
• Survived 2 years or more following treatment
• Able to complete neuropsychological and neuroimaging parts of the study
• Signed a written informed consent in accordance with institutional guidelines

Exclusion criteria

• Subject has experienced recurrent disease
• Subject has a contraindication for MRI
• Subject has a contraindication for neuropsychological testing
• Subject has stage IV or V renal insufficiency

Trial design

80 participants in 1 patient group

1

Description:

Subjects with PCNSL who have survived disease-free for 2 years or more. Treatments will vary depending upon site of enrollment and will include chemotherapy, blood brain barrier disruption (BBBD) with chemotherapy, radiation, and stem cell transplantation.