Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

NCT00481637 | Completed

• 1 other identifier: RDA-0269
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

paraneoplastic; autoimmunity;

Outcome Measures

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.

  Duration of study

Study Arms (2)

Cancer patients

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

Normal

Normal volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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\* 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Neoplasms; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Robert Darnell, MD, PHD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: March 1, 1998
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)