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Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

This study is currently recruiting participants.
Verified January 2017 by Rockefeller University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481637
First Posted: June 4, 2007
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rockefeller University
June 1, 2007
June 4, 2007
January 4, 2017
March 1998
December 2020   (Final data collection date for primary outcome measure)
Assessment of PND antibody titer, CTL activity, and clinical data in neurologically normal patients with SCLC and gynecologic tumors, with tumors unrelated to PNDs, and in normal control patients. [ Time Frame: Duration of study ]
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Complete list of historical versions of study NCT00481637 on ClinicalTrials.gov Archive Site
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Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients
Tumor Immunity in Neurologically Normal 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.
See brief description
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
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.
Cancer
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  • Cancer patients
    SCLC and gynecological cancer patients and unrelated cancer patients with presence of PND-specific CTLs.
  • Normal
    Normal volunteers
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2020
December 2020   (Final data collection date for primary outcome measure)

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* VDRL negative if tested* No known IV drug users HgB > 8.5 WBC > 3,800 Platelets > 120,000 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 CNS metastasis on clinical exam 3. No chemotherapy within 1 month 4. No NYHA class III/IV status 5. No pulmonary disease which limits daily activities 6. No anticoagulation therapy

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Mayu Frank, MS ANP 212-327-7443 frankm@rockefeller.edu
United States
 
 
NCT00481637
RDA-0269
No
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Rockefeller University
Rockefeller University
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Principal Investigator: Robert Darnell, MD, PHD Rockefeller University
Rockefeller University
January 2017