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

This study has been terminated.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00710151
First received: July 2, 2008
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Primary Central Nervous System Lymphoma (PCNSL)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurotoxicity in Primary Central Nervous System Lymphoma: An International, Collaborative, Observational Study of Cognition in Long-Term Survivors

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Neuropsychological Functioning [ Time Frame: More than 2 years after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI [ Time Frame: More than 2 years after treatment ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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, BBBD with chemotherapy, radiation, and stem cell transplantation.

Detailed Description:

This is an international, multi-center project that will enroll as many as 118 subjects of which approximately 35 will be enrolled at 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 MR images as well as examine the contribution of factors such as radiation, age, surgery, chemotherapy etc. to cognition.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals who have had PCNSL and have survived disease-free for 2 years or more.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710151

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Germany
Charite University Medicine
Berlin, Germany
University of Bochum
Bochum, Germany
University Medical Center
Freiburg, Germany
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Edward A Neuwelt, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00710151     History of Changes
Obsolete Identifiers: NCT00706472
Other Study ID Numbers: OHSU-4093, RO1 NS33618
Study First Received: July 2, 2008
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by OHSU Knight Cancer Institute:
neurotoxicity
cognition in survivors
diagnostic imaging

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 22, 2013