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

Paraneoplastic Syndromes Clinical Trial

Official title:

Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327236
• Other study ID #: RDA-0148
• Status: Completed
• Start date: January 1995
• Est. completion date: February 2018

Study information

• Verified date: April 2019
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Paraneoplastic Syndromes
• Syndrome

Locations

Country	Name	City	State
United States	Rockefeller University Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunologic responses to tumor antigens in vitro	ELISPOT	throughout study