NCT00861107

In-Situ Therapeutic Cancer Vaccine for Metastatic Cancer Combining AlloStim With Tumor Cryoablation

Phase I/II Study of a Therapeutic Cancer Vacccine Created In-situ in Patients With Refractory or Metastatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mirror Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II study to investigate the feasibility of creating a personalized therapeutic cancer vaccine within the body. A vaccine contains a source of tumor antigen and an adjuvant. In this study, tumor antigen is generated by freezing a tumor by a minimally invasive percutaneous (through the skin) cryoablation procedure. The study drug, AlloStim, is injected into the ablated tumor to promote development of an anti-tumor immune response.

Detailed description

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.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AlloStim-7	intradermal injection once a week for 3 weeks
PROCEDURE	percutaneous tumor cryoablation	ablation of a tumor by percutaneous cryoablation under CT guidance
BIOLOGICAL	AlloStim-7	intratumoral injection into cryoablated tumor lesion 1 hour after ablation
BIOLOGICAL	AlloStim8 or AlloStim-9	intravenous infusion of AlloStim one week following ablation procedure. First cohort to receive 10\^8 cell dose and if no toxicity dose escalates to 10\^9 cell dose.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2009-03-13
• Last updated: 2011-06-08

Locations

1 site across 1 country: United States