Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients
Verified November 2013 by Rockefeller University
Information provided by (Responsible Party):
First received: June 1, 2007
Last updated: November 12, 2014
Last verified: November 2013
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Tumor Immunity in Neurologically Normal Patients
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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
SCLC and gynecological cancer patients and unrelated cancer patients with presence of PND-specific CTLs.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Males and females ages 25 -75
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)
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00481637
|Rockefeller University Hospital
|New York, New York, United States, 10021 |
|Contact: Mayu Frank, MS ANP 212-327-7443 |
|Principal Investigator: Robert Darnell, MD, PHD |
||Robert Darnell, MD, PHD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 1, 2007
||November 12, 2014
||United States: Institutional Review Board
Keywords provided by Rockefeller University:
ClinicalTrials.gov processed this record on April 16, 2015