Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

Tumor Immunity in Neurologically Normal Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00481637

Enrollment

Registered

2007-06-04

Start date

1998-03-31

Completion date

2013-05-31

Last updated

2019-04-17

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

Conditions

Cancer

Keywords

paraneoplastic; autoimmunity;

Brief summary

The purpose of this study is to study whether immune cells capable of killing tumors that express proteins associated with paraneoplastic neurologic syndrome (PNS) can be found in small cell lung cancer and ovarian cancer patients. The presence of these cells may play a role in tumor immunity in these patients. The protocol involves neurological examinations and collection of blood.

Detailed description

See brief description

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Males and females ages 25 -75 2. If leukapheresis: Hepatitis B surface antigen negative if tested\* Hepatitis C antibody negative if tested\* HIV antibody negative if tested\* Venereal disease reaction level (VDRL) negative if tested\* No known IV drug users Hemoglobin \> 8.5 White blood cell count \> 3,800 Platelets \> 120,000 International normalized ratio (INR) \< 2 (verified only if clinically indicated) 3. If large blood draw (1/2 to 1 unit) in lieu of leukapheresis: Hepatitis B surface antigen negative if tested\* Hepatitis C antibody negative if tested\* HIV antibody negative if tested\* VDRL negative if tested\* No known IV drug users HgB \> 10.0 WBC \> 3,800 Platelets \> 120,000 INR \< 2 (verified only if clinically indicated)

Exclusion criteria

No known neurologic disease 2. No known central nervous system (CNS) metastasis on clinical exam 3. No chemotherapy within 1 month 4. No New York Heart Association class III/IV status 5. No pulmonary disease which limits daily activities 6. No anticoagulation therapy

Design outcomes

Primary

Measure	Time frame
Paraneoplastic neoplastic disease antibody titer, Cytotoxic T Lymphocyte activity, and clinical data in neurologically normal patients with small cell lung cancer and gynecologic tumors, with tumors unrelated to PNDs, and in normal control patients.	Duration of study

Countries

United States

Outcome results