Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With

Status Completed

Clinical Trial Summary

A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is intentionally mis-matched immune cells (AlloStim-TM) engineered to produce inflammatory cytokines.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Breast Cancer
Colorectal Cancer
Colorectal Neoplasms
Melanoma
Non-small Cell Lung Cancer
Ovarian Cancer
Ovarian Neoplasms
Prostate Cancer
Prostatic Neoplasms
Sarcoma
Solid Tumors Stage II, Stage III and Stage IV

Clinical Trial Details

NCT number	NCT01065441
Study type	Interventional
Source	Immunovative Therapies, Ltd.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 2010
Completion date	July 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms