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

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.

Conditions

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

Interventions

BIOLOGICAL

AlloStim

Patients meeting eligibility criteria will be primed with at least three and up to nine intradermal AlloStim-TM injections at a frequency of every 2-8 days at doses between 1-4 x 10\^7 cells

PROCEDURE

Cryoablation

Percutaneous cryoablation of selected tumor lesion under CT or US guidance

BIOLOGICAL

AlloStim

intratumoral injection of AlloStim-TM into cryoablated tumor lesion at a dose of 1-6 x 10\^7 cells

BIOLOGICAL

AlloStim

intravenous AlloStim-TM at doses between 1 x 10\^7 to 1 x 10\^9 cells

BIOLOGICAL

AlloStim

Intraperitoneal AlloStim-TM infusion in patients with peritoneal carcinomatosis and/or ascites

BIOLOGICAL

AlloStim

Patients with malignant pleural effusion may receive intrapleural AlloStim-TM infusion at a dose of 5-10 x 10\^7 cells.

BIOLOGICAL

AlloStim

Patients with palpable tumors may receive alcohol ablation and intratumoral AlloStim-TM

Sponsors & Collaborators

• Hadassah Medical Organization

  collaborator OTHER

• Michael Har-Noy

  lead INDUSTRY

Principal Investigators

• Tamar Peretz, MD · Hadassah Medical Organization

• Dr. Michael Har-Noy · Mirror Biologics, Inc.

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2012-12-31

Completion

2013-07-31

Countries

• Israel

Study Locations