The NCI Surgery Branch has developed experimental therapies that involve taking white blood
cells from patients' tumor or from their blood, growing them in the laboratory in large
numbers, and then giving the cells back to the patient.
This study will collect white blood cells from normal volunteers and white blood cells and/or
tumor cells, from patients who have been screened for and are eligible for a NCI Surgery
Branch treatment protocol. The cells collected from normal volunteers will be used as growth
factors for the cells during the period of laboratory growth. The cells and/or tumor from
patients will be used to make the cell treatment product.
Patients must be eligible for a NCI Surgery Branch Treatment Protocol
Normal Volunteers must meet the criteria for blood donation
Both patients and normal Volunteers will undergo apheresis. Patients will then undergo
further testing as required by the treatment protocol.
There is no required follow up for normal volunteers.
There are numerous clinical trials underway in the Surgery Branch, NCI 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
This protocol is also designed to serve as a biorepository for samples and associated data
collected on patients enrolled on Surgery Branch protocols, which are now closed. Patients
who were enrolled prior to 2003 were not enrolled on this protocol. Their tissue and data
will now be retained on this protocol for long-term storage. The protocol is concerned with
the retention of serum, CSF, bone marrow, ascites fluid, PBMCs, tumor, healthy tissue
samples, and CD34 purified HSCS samples collected from patients with cancer to support basic
science and clinical research activities of the Surgery Branch (SB) at the NIH Clinical
Research Center and Center for Cancer Research.
- To obtain autologous blood, stem cells and/or tumor tissue from patients currently with
cancer for laboratory analysis and ex vivo generation of autologous anti-tumor
lymphocytes for future enrollment on a Surgery Branch adoptive cell therapy clinical
- To obtain allogeneic PBMC via apheresis, or blood samples from healthy volunteers for
use in generating anti-tumor patient lymphocytes ex vivo.
- To conduct genomic, proteomic and immunologic research studies on samples collected.
Patients with cancer must be 16 years of age or older and meet the laboratory safety testing
for infection included in all the cell therapy treatment trials.
Healthy volunteers must meet the safety evaluation criteria established by the FDA for
donation of blood products including HIV, HCV, HTLV, CMV, HBsAg, HBc, Trypanosoma cruzi,
syphilis, and West Nile Virus. They must also meet the strict behavioral and medical history
Once a cancer patient is determined to be a potential candidate for one of the Surgery Branch
clinical trials, they will undergo an apheresis and/or tumor resection for future treatment
and/or research purposes. In addition, this protocol will allow for the pheresis of healthy
volunteers for allogeneic PBMC used in generating autologous antitumor lymphocytes in the
laboratory, or for research purposes.
No treatments, investigational or standard therapy, will be administered on this protocol.
- ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER:
- Patients must have a form of cancer currently being studied with adoptive cell
therapies in the Surgery Branch.
- Ability of subject or Legally Authorized Representative to understand and sign the
Informed Consent Document.
- All participants greater than 18 years of age must be willing to sign a durable power
- Patients must be greater than or equal to 16 years of age.
- Clinical performance status of ECOG 0 or 1.
- Seronegative for HIV (The experimental treatments being evaluated depend upon an
intact immune system. Patients who are HIV seropositive can have decreased immune
competence and thus be less responsive to the experimental treatment and more
susceptible to its toxicities).
- Seronegative for hepatitis B surface antigen and seronegative for antibody to
hepatitis C. If hepatitis C antibody test is positive, then patients must be tested
for the presence of antigen by RT-PCR and be HCV RNA negative.
- If Surgery is required to obtain TIL for cell acquisition, the expected procedure must
be associated with minimal morbidity and minimal hospitalization.
- Active systemic infections, coagulation disorders, or other major medial illnesses of
the cardiovascular, respiratory, or immune system.
- Patients who cannot give proper informed consent to the adoptive cell experimental
therapy due to an active psychiatric disorder or inability to understand the nature of
the proposed therapy and attendant risk.
ELIGIBILITY CRITERIA FOR NORMAL DONORS:
- Normal donors must be greater than or equal to 18 years of age.
- Seronegative for HBsAg, Anti-HBc, Anti-HCV, Anti-HIV-1/2, HIV- 1/HCV/HBV NAT,
anti-HTLV-1/2, RPR, T. cruzi, and West Nile Virus NAT
- Normal donors must meet the strict behavioral and medical history requirements
- Has had babesiosis.
- Is at risk or has Creutzfeld-Jakob Disease.
- Is on steroid therapy or any other medication or has received vaccination that might
interfere with cell preparation per Principal Investigator s discretion.
- Has ongoing illness that would cause harm to the volunteer during the apheresis
procedure as determined by the Principal Investigator.
- 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 xenotransplantaion at any time.
- Has received a dura mater graft.
- If female, has been pregnant in the last six weeks
- Has had body piercing or tatoos within the past year
- Has spent time outside the United States to a restricted country
- Has participated in any high-risk activities