Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rockefeller University
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00481637
First received: June 1, 2007
Last updated: November 14, 2013
Last verified: November 2013

June 1, 2007
November 14, 2013
March 1998
December 2015   (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 ] [ Designated as safety issue: No ]
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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.

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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.

Healthy
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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 2015
December 2015   (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

Both
18 Years and older
Yes
Contact: Mayu Frank, MS ANP 212-327-7443 frankm@rockefeller.edu
United States
 
NCT00481637
RDA-0269
No
Rockefeller University
Rockefeller University
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Principal Investigator: Robert Darnell, MD, PHD Rockefeller University
Rockefeller University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP