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

NCT00861107 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-06-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Mirror Biologics, Inc.

    lead INDUSTRY

Principal Investigators

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

  • Michael Berger, MD · Immunotherapy Clinical Associates, PC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-03-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861107 on ClinicalTrials.gov