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Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

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ClinicalTrials.gov Identifier: NCT00481637
Recruitment Status : Recruiting
First Posted : June 4, 2007
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Cancer

Detailed Description:
See brief description

Study Design

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Tumor Immunity in Neurologically Normal Patients
Study Start Date : March 1998
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Groups and Cohorts

Group/Cohort
Cancer patients
SCLC and gynecological cancer patients and unrelated cancer patients with presence of PND-specific CTLs.
Normal
Normal volunteers


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with SCLC and gynecologic (breast or ovarian) tumors and patients with unrelated cancers. Also healthy volunteers will be included as a comparison group in this study.
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481637


Contacts
Contact: Mayu Frank, MS ANP 212-327-7443 frankm@rockefeller.edu

Locations
United States, New York
Rockefeller University Hospital Recruiting
New York, New York, United States, 10021
Contact: Mayu Frank, MS ANP    212-327-7443      
Principal Investigator: Robert Darnell, MD, PHD         
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Robert Darnell, MD, PHD Rockefeller University
More Information

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00481637     History of Changes
Other Study ID Numbers: RDA-0269
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Rockefeller University:
paraneoplastic; autoimmunity;