Phase I/II Study of a Therapeutic Cancer Vacccine Created In-situ in Patients With Refractory or Metastatic Cancer
This is a Phase I/II clinical study to investigate the feasibility of creating a
personalized anti-tumor vaccine within the body of patients with advanced cancers. The aim
of the study is to evaluate the safety of administration and anti-tumor effect of a vaccine
protocol that has three separate phases. Cancer patients generally present with an immune
response to cancer biased to a Th2 response, while a Th1 response is considered necessary
for mediating anti-tumor immunity. The first step of the study consists of three (3) weekly
intradermal priming doses of AlloStim. The aim of this step is to create Th1 immunity to
the alloantigens in AlloStim, thus increasing the number of Th1 cells in circulation. The
second step of the protocol involves the cryoablation of a selected tumor lesion followed by
an intratumoral AlloStimTM injection. The aim of this step is to generate tumor-specific CTL
killer cells in the circulation. The final step is an intravenous infusion of AlloStim. The
aim of this step is to activate circulating Th1 cells, killer cells, and natural killer
cells The further aim of this step is to create an inflammatory environment that can
break-down the ability of the tumor to avoid an anti-tumor immune response.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
evaluation of any drug-related toxicity associated with AlloStim administration as well as the reversibility of such toxicity.
Dr. Michael Har-Noy
Immunovative Therapies, Ltd.
United States: Food and Drug Administration
|Immunovative Clinical Research, Inc||Carlsbad, California 92010|