Combination of External Beam Radiation With Intratumoral Injection of Dendritic Cells as Neo-adjuvant Treatment of High-risk Soft Tissue Sarcoma Patients
Pre-treatment test will consist of a blood draw for anti-tumor immune response and Hepatitis
B, Hepatitis C, Human Immunodeficiency Virus (HIV) tests. A biopsy with collection of tumor
cells. Assays (ELISPOT and flow cytometry) to test for the intended anti-tumor cell T cell
response will be performed on biopsy specimens as well as standard pathology department
review of specimens for diagnosis and assessment of necrosis and apoptosis. Labs are also
drawn for surgical specimens and post-therapy immunity assays.
Prior to commencing therapy, a procedure called leukapheresis (peripheral blood mononuclear
cell) isolation will be conducted and twenty-four hours prior to intended injection, the
dendritic cells will be harvested and assessed for quality control. Prior to injection (the
clinical target is the gross tumor), history and physical examination will be performed.
Toxicity will be assessed according to Common Terminology Criteria (CTC). The plan will be
to inject the entire dendritic cell product evenly throughout the tumor.
Conventional therapy consists of external beam radiation therapy, 25 fractions from day 1-33
administered Monday through Friday only. The experimental therapy, dendrite cell (DC)
injections will occur during the course of the external beam radiation therapy. DC
injections will be prepared from frozen white blood cells and injected at four intervals on
day 12, 19, 26, and day 33.
DCs will be labeled (with a radioisotope) and injected intratumorally before surgery.
Patients will be randomized into one of three groups. One group will receive injection of
labeled DCs 72 hrs before surgery, second group - 48 hrs, and third group 24 hrs before
surgery. Surgery will occur on day 50 for tumor removal.
If the experimental treatment causes a measurable change in the immune blood tests, there
will be office visits, every 3 months for 2 years. In the longer term, there will be office
visits at 6 month intervals for the third year, and yearly thereafter. A computed tomography
(CT) scan of chest and magnetic resonance imaging (MRI) scan of extremity will be performed
at every office visit.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of Combined Neo-Adjuvant Treatment with Apoptosis-Inducing Therapy
Determine if combined neo-adjuvant treatment with apoptosis-inducing therapy (gamma-irradiation) plus intratumoral DC administration will induce a T lymphocyte immune response specific for soft tissue sarcoma associated antigens.
Average of 6 Months
Scott Antonia, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|