The Study of Immune Cell (T Cell) Activity in Patients With Paraneoplastic Neurologic Syndromes

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Rockefeller University
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00327236
First received: May 17, 2006
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

The investigators believe that T cells, cells that are a part of the immune system, are what are causing the neurological problems while also attacking tumor cells. This protocol studies the clinical status of patients with paraneoplastic neurological disorder (PND) as well as their blood to understand the relationship between their neurological disease, their cancer, and their immune system.


Condition
Paraneoplastic Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes

Further study details as provided by Rockefeller University:

Biospecimen Retention:   Samples With DNA

serum, cells)


Estimated Enrollment: 100
Study Start Date: January 1995
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Patients with paraneoplastic neurological disorders (PNDs) provide a unique model for studying tumor immunity and neuronal autoimmunity. We hypothesize that T lymphocyte autoimmune dysfunction is involved in the pathogenesis of the paraneoplastic neurological syndromes, and that killer T cells are involved in the targeting and successful killing of tumor cells in these cancer patients. Furthermore, we postulate that this activity may provide a model for autoimmune brain disease. We will assess the immune responses in PND patients, correlate these with the clinical data (time course of disease, symptoms and signs, disability), and collect and archive clinical data, serum and cells from PND patients for current and future studies into the basic immune system phenomenon present in PND patients.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with paraneoplastic neurologic disease, diagnosed through the research lab of the PI, or from third party referrals in the NYC area.

Criteria

Inclusion Criteria:

  • Neurological disease which is suspected to be paraneoplastic
  • No known active additional malignancy other than non-melanoma skin cancer

Exclusion Criteria:

  • Known central nervous system (CNS) metastasis
  • Known active additional malignancy

if leukapheresis: No known hepatitis B or C, HIV, or syphilis (by history or prior negative tests) no known IV drug users HgB > 8.5 WBC > 3,500 platelets > 100,000 INR < 2

if large blood draw (1/2 to 1 unit; children 3 ml/kg) in lieu of leukapheresis: no known IV drug users HgB > 10 WBC > 3,500 platelets > 100,000 INR < 2 if lumbar puncture: platelets > 120,000 INR < 1.2

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327236

Contacts
Contact: Mayu Frank, NP 212-327-7454 frankm@rockefeller.edu

Locations
United States, New York
Rockefeller University Hospital Recruiting
New York, New York, United States, 10021
Contact: Mayu Frank, NP    212-327-7443    frankm@rockefeller.edu   
Principal Investigator: Robert Darnell, MD, PHD         
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Robert Darnell, MD, PHD Rockefeller University
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00327236     History of Changes
Other Study ID Numbers: RDA-0148
Study First Received: May 17, 2006
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Paraneoplastic Neurologic Syndromes

Additional relevant MeSH terms:
Syndrome
Paraneoplastic Syndromes, Nervous System
Paraneoplastic Syndromes
Disease
Pathologic Processes
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Neurodegenerative Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014