Harvesting Cells for Experimental Cancer Treatments

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, 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 NCI (SB) at the NIH Clinical Research Center and Center
for Cancer Research.

OBJECTIVES:

- 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 NCI-SB adoptive cell therapy clinical trial.

- 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.

ELIGIBILITY:

Patients with cancer must be >15 years of age 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 HBsAg, HBc, HCV, Trypanosoma cruzi, West Nile Virus,
CMV, syphilis, and other requirements as updated on the FDA website.They must also meet the
strict behavioral and medical history requirements.

DESIGN:

Once a cancer patient is determined to be a potential candidate for one of the NCI SB
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:

INCLUSION CRITERIA:

- Patients must have a form of cancer currently being studied with adoptive cell
therapies in the NCI-SB.

- Patient, or their parent(s)/legal guardian(s) (if the patient is less than 18 years of
age), is able to understand and willing to sign a written Informed consent document.

- Age greater than or equal to 15 years

- All participants greater than 18 years of age must be willing to sign a durable power
of attorney.

- Clinical performance status of ECOG 0 or 1.

- Serology

- Seronegative for HIVantibody. (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 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.

- 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:

- Healthy volunteers age greater than or equal to 18 years.

- Seronegative 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, anti-CMV, RPR, and other
requirements as updated on the FDA website:
https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm095440.h
tm#approved.

- Healthy donors volunteers must meet the strict behavioral and medical history
requirements

EXCLUSION CRITERIA:

- 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, is pregnant or has given birth within 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.