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

Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00327236

Enrollment

109

Registered

2006-05-18

Start date

1995-01-31

Completion date

2018-02-28

Last updated

2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraneoplastic Syndromes

Keywords

Paraneoplastic Neurologic Syndromes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results