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CompletedNCT00481637Updated Apr 17, 2019

Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

An observational study in Cancer, sponsored by Rockefeller University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Rockefeller University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

See brief description

02

Conditions studied

  • Cancer

Keywords

  • paraneoplastic; autoimmunity;
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In context

Lead sponsor

Rockefeller University is the lead sponsor of 120 studies on the registry; 3 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
33 participants (actual)

Groups and cohorts

  • Cancer patients

    SCLC and gynecological cancer patients and unrelated cancer patients with presence of PND-specific CTLs.

  • Normal

    Normal volunteers

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Rockefeller University Hospital
    New York, New York 10021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00481637
Lead sponsor
Rockefeller University
Responsible party
Sponsor
First posted
Jun 4, 2007
Start date
Mar 1998
Primary completion
May 2013
Completion
May 2013
Last update
Apr 17, 2019

Study contacts

Robert Darnell, MD, PHD
principal investigator · Rockefeller University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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