Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

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.

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Key information

Conditions

Cancer Autoimmune Diseases Immune System Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rockefeller University Hospital

New York, 10021, United States

About this study

See brief description

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females ages 25 -75
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)

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

Treatment and study plan

Primary outcomes

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.

Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Official study title

Tumor Immunity in Neurologically Normal Patients

Important dates

Study start: 1998
Primary completion: 2013
Study completion: 2013
First posted: Jun 4, 2007
Registry last updated: Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed