Trial Information

Phase I/II Study of Autologous Tumor Cell Vaccination Using Metronomic Cyclophosphamide, 3-Dimensional Conformal Radiotherapy, Intra/Peri-Tumor Injection of Poly ICLC With Trans-Hepatic Arterial Embolization Followed by Poly ICLC Boosting in Patients With Unresectable, Recurrent, or Metastatic Cancers in the Liver (Hepatoma, Cholangiocarcinoma, Neuroendocrine, Breast, Colon, Gastric, and Esophageal Cancer)

OBJECTIVES:

- To study the safety and effectiveness of a strategy to establish robust anticancer
immunologic body defenses by using low-dose radiation therapy to the liver cancer in
order to increase tumor targetability; inject a body defense activator,
polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC, hiltonol,
oncovir), into and around the cancer to activate sentinel dendritic cells to alarm body
defenses; and shut down local production of factors that suppress the body's natural
anticancer defenses by starving the cancer of its blood supply within the liver.

OUTLINE: Patients receive low-dose oral cyclophosphamide once daily on days 1-21 and undergo
3-dimensional conformal radiotherapy on days 21-23. On day 24, patients undergo an intra- or
peri-tumoral polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC)
injection directly into the tumor followed by trans-hepatic artery embolization to the
designated tumor. Patients receive poly ICLC subcutaneously on days 26, 35, 37, 42, 44, 49,
and 51. Treatment repeats every 57 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months thereafter.