Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols
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 enrollment.
- 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
trial, or for research purposes.
- To obtain autologous blood from patients with a history of cancer who currently have no
evidence of disease for research purposes.
- To obtain allogeneic PBMC via apheresis, or blood samples from normal volunteers for
use in generating anti-tumor patient lymphocytes ex vivo, or for research.
- To obtain PBMC via apheresis, blood samples, and skin biopsies from subjects with
spontaneous vitiligo for research purposes.
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.
Normal 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
requirements. Patients with a history of cancer who currently have no evidence of disease
and subjects with spontaneous vitiligo must meet the laboratory safety testing for infection
and other criteria outlined in the protocol.
Once a cancer patient is determined to have a cell product that meets the requirements of
one of the Surgery Branch clinical trials, the candidate will be screened according to the
eligibility evaluation of the prospective adoptive cell therapy trial, if eligible, the
patient 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 normal
volunteers for allogeneic PBMC used in generating autologous anti-tumor lymphocytes in the
laboratory, or for research purposes. This protocol will also allow for apheresis of
patients with a history of cancer, and apheresis and , blood samples and skin biopsies in
subjects with spontaneous vitiligo.
No treatments, investigational or standard therapy, will be administered on this protocol.
Steven A Rosenberg, M.D.
National Cancer Institute (NCI)
United States: Federal Government
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