Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients
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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 |
|---|
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Healthy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Tumor Immunity in Neurologically Normal Patients |
- 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: | 10 |
| Study Start Date: | March 1998 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Cancer patients
SCLC and gynecological cancer patients and unrelated cancer patients with presence of PND-specific CTLs.
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Normal
Normal volunteers
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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| Contact: Mayu Frank, MS ANP | 212-327-7443 | frankm@rockefeller.edu |
| 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 | |
| Principal Investigator: | Robert Darnell, MD, PHD | Rockefeller University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00481637 History of Changes |
| Other Study ID Numbers: | RDA-0269 |
| Study First Received: | June 1, 2007 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rockefeller University:
|
To evaluate immune responses in neurologically normal cancer patients |
ClinicalTrials.gov processed this record on May 16, 2013