Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

NCT ID: NCT00481637

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-03-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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See brief description

Conditions

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Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer patients

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

No interventions assigned to this group

Normal

Normal volunteers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rockefeller University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Darnell, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

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Rockefeller University Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RDA-0269

Identifier Type: -

Identifier Source: org_study_id

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