Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

This study is currently recruiting participants.

Verified by Rockefeller University, April 2009

First Received: June 1, 2007 Last Updated: April 7, 2009 History of Changes

Sponsored by:	Rockefeller University
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00481637

Purpose

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
Healthy

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Tumor Immunity in Neurologically Normal Patients

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10
Study Start Date:	March 1998

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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:

Males and females ages 25 -75
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)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Rockefeller University ( Robert Darnell, MD, PhD )
Study ID Numbers:	RUH IRB #RDA-269
Study First Received:	June 1, 2007
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00481637 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rockefeller University:

To evaluate immune responses in neurologically normal cancer patients

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009