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

Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes

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.

Study Overview

• Status: Completed
• Conditions: Paraneoplastic Syndromes

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.

• Study Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Rockefeller University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunologic responses to tumor antigens in vitro	ELISPOT	throughout study

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Robert Darnell, MD, PhD, Rockefeller University

Study record dates

Study Major Dates

• Study Start: January 1, 1995
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: May 17, 2006
• First Submitted That Met QC Criteria: May 17, 2006
• First Posted (Estimate): May 18, 2006

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Paraneoplastic Neurologic Syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms; Neoplasms by Site; Disease; Neurodegenerative Diseases; Nervous System Neoplasms; Syndrome; Paraneoplastic Syndromes; Paraneoplastic Syndromes, Nervous System
• Other Study ID Numbers: RDA-0148