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| Sponsor: | Immunovative Therapies, Ltd. |
|---|---|
| Information provided by: | Immunovative Therapies, Ltd. |
| ClinicalTrials.gov Identifier: | NCT00861107 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer |
Biological: AlloStim-7 Procedure: percutaneous tumor cryoablation Biological: AlloStim8 or AlloStim-9 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of a Therapeutic Cancer Vacccine Created In-situ in Patients With Refractory or Metastatic Cancer |
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
PT/INR ≤ 1.5
Exclusion Criteria:
Chronic use (> 2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 30 days of the first day of study drug treatment
Contacts and Locations| United States, California | |
| Immunovative Clinical Research, Inc | |
| Carlsbad, California, United States, 92010 | |
| Study Director: | Dr. Michael Har-Noy | Immunovative Therapies, Ltd. |
| Principal Investigator: | Michael Berger, MD | Immunotherapy Clinical Associates, PC |
More Information
| Responsible Party: | Dr. Michael Har-Noy, Immunovative Therapies, Ltd |
| ClinicalTrials.gov Identifier: | NCT00861107 History of Changes |
| Other Study ID Numbers: | ITL-002-CRYO |
| Study First Received: | March 12, 2009 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Colorectal cancer Breast Cancer Melanoma GI cancer |
Prostate cancer Kidney cancer Lung cancer all types metastatic cancer where at least one tumor lesion is accessable for percutaneous cryoablation |
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |