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 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 potential future enrollment on an NCI-SB adoptive cell therapy clinical
trial.
To obtain allogeneic PBMC via apheresis, whole blood, or other blood products from
healthy volunteers, for use in generating anti-tumor patient lymphocytes ex vivo.
To conduct genomic, proteomic, and immunologic research studies on samples collected from
patients with a current diagnosis of cancer.
Eligibility:
Patients with cancer must be >= 18 years of age and meet the laboratory safety testing
for infection included in all treatment trials.
Healthy volunteers for PBMC donation must meet the safety evaluation criteria established
by the FDA for donation of blood products. They must also meet the strict behavioral and
medical history requirements.
Healthy volunteers for whole blood donation must meet the safety evaluation criteria
established by the NIH Clinical Center Department of Transfusion Medicine (DTM) Blood
Bank for screening of allogeneic whole blood donors.
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
apheresis of healthy volunteers for allogeneic PBMC or donation of whole blood for
processing into serum for use in generating autologous anti-tumor lymphocytes in the
laboratory, or for research purposes.
No treatments, investigational or standard therapy, will be administered on this
protocol.
