Harvesting Cells for Experimental Cancer Treatments

Launched by NATIONAL CANCER INSTITUTE (NCI) · Sep 3, 2003

Keywords

ClinConnect Summary

Background:

There are numerous clinical trials underway in the National Cancer Institute Surgery Branch (NCI-SB) in which patients are administered autologous lymphocytes with anti-tumor activity generated from either peripheral blood mononuclear cells (PBMC) or tumor-infiltrating lymphocytes (TIL). All adoptive cell therapy protocols require that certain cell criteria be evaluated and met prior to enrollment.

This protocol is also designed to serve as a biorepository for samples and associated data collected on patients enrolled on NCI-SB protocols, current and historical. Patients who w...

Gender

ALL

Eligibility criteria

• * ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER:
• INCLUSION CRITERIA:
• • Patients must have a form of cancer currently being studied in the NCI-SB.
• • Patient is able to understand and willing to sign a written informed consent document.
• • Age greater than or equal to 18 years.
• • Clinical performance status of ECOG 0 or 1.
• • Serology
• • Seronegative for HIV antibody. (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities).
• • Seronegative for hepatitis B surface antigen and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
• • Lesions which will be harvested for the generation of TIL should be accessible via standard surgical or radiological techniques and be associated with acceptable morbidity.
• EXCLUSION CRITERIA:
• • Active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.
• • Patients who cannot give proper informed consent to the experimental therapy due to an active psychiatric disorder or inability to understand the nature of the proposed therapy and attendant risk.
• • Women of child-bearing potential who are pregnant because of the potentially dangerous effects of some of the procedures (e.g., tumor biopsy or surgery for tumor resection) on the fetus.
• ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS:
• INCLUSION CRITERIA for PBMC Donors:
• • Age greater than or equal to 18 years.
• • Non-reactive for HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2, HBV/HCV/HIV-1 NAT, anti-HTLV-I/II, anti-T. cruzi, West Nile Virus NAT,syphilis, and babesia.
• • PBMC donors must meet the strict behavioral and medical history requirements as per applicable NCI-SB Apheresis Donor SOP(s).
• INCLUSION CRITERIA FOR WHOLE BLOOD DONORS:
• • Age greater than or equal to 18 years.
• • Whole blood donors must meet the DTM inclusion criteria for allogeneic whole blood donation.
• EXCLUSION CRITERIA for PBMC Donors:
• • Has had babesiosis.
• • Is at risk or has Creutzfeldt-Jakob Disease.
• • Is on steroid therapy or any other medication or has received vaccination that might interfere with cell preparation per Principal Investigator s (PI) discretion.
• • Has ongoing illness that would cause harm to the volunteer during the apheresis procedure as determined by the PI.
• • Has had yellow jaundice, liver disease, or hepatitis since the age of 11.
• • Has uncontrolled diabetes.
• • Has a hematologic malignancy or any bleeding abnormalities.
• • Has received any type of organ transplant in the past 12 months.
• • Has undergone xenotransplantation at any time.
• • Has received a dura mater graft.
• • If female, is pregnant or has given birth within the last six weeks.
• • Has had an ear or body piercing or tattoos within the past 12 months.
• • Has had a blood transfusion within the past 12 months.
• • Has spent time outside the United States to a restricted country.
• • Has participated in any high-risk activities.
• EXCLUSION CRITERIA for Whole Blood Donors:
• • - Whole blood donors who do not meet the DTM criteria for allogeneic whole blood donation.