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)

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.