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

NCT ID: NCT00327236

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1995-01-31
• Study Completion Date: 2018-02-28

Brief Summary

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.

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.

Conditions

Paraneoplastic Syndromes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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
• No pulmonary disease which limits daily activities

if leukapheresis: must be 14 or older 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 must be 14 or older

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockefeller University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Darnell, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

Rockefeller University Hospital

New York, New York, United States

Countries

United States

Other Identifiers

RDA-0148

Identifier Type: -

Identifier Source: org_study_id