A Phase I/II Study of an Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancers
This is a Phase I/II clinical study to investigate the optimal protocol and indication for
creating a personalized anti-tumor vaccine within the body of patients with cancer. The aim
of the study is to evaluate the safety of administration and anti-tumor effect of a vaccine
protocol that has three separate steps. 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 multiple
intradermal priming doses of AlloStimTM. The aim of this step is to create Th1 immunity to
the alloantigens in AlloStimTM, 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 AlloStimTM.
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. In patients with
partial responses and recurrence of disease, additional intravenous "booster" infusions are
utilized to reactivate the circulating immune cells.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the evaluation of any drug-related toxicity associated with AlloStimTM administration as well as the reversibility of such toxicity.
90 days
Yes
Tamar Peretz, MD
Principal Investigator
Hadassah Medical Organization
Israel: Ministry of Health
ITL-002-HMC
NCT01065441
December 2009
July 2012
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