An Individualized Anti-Cancer Vaccine Study in Patients With HCC

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and the immunological, radiological, and pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients with refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC treatments or have failed all approved HCC treatments. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of these two components provides a vaccine designed to bring out an immune response capable of finding and killing the tumor cells.

Detailed Description
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All accrued subjects will undergo tumor harvest procedure. The tumor samples will be processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine. This study consists of three phases: priming phase, vaccination phase, and activation phase. The priming phase involves intradermal injections of AlloStim(TM). The aim of this phase is to increase the titer of Th1 immune cells in circulation. The vaccination phase involves the intradermal injections of AlloSim(TM) immediately followed by the intradermal injections of CRCL. This phase is designed to elicit tumor-specific immunity. The activation phase involves intravenous infusion of AlloStim(TM). This phase is designed to activate memory cells and NK cells and cause them to extravasate and traffic to tumor sites.

Official Title
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An Individualized Anti-Cancer Vaccine (AlloVaxTM) Study in Patients With Refractory Hepatocellular Carcinoma (HCC)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: AlloVax
* Biological: CRCL
* Biological: AlloStim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any Patients with a diagnosis of HCC based on histology or the current accepted radiological measures. Age > 18 years. Patient has an MRI or CT result (positive for HCC) up to 3 months prior to recruitment. AFP > 30. Patient who is not eligible or failed all approved HCC treatments. Exclusion Criteria: Patient is unable or unwilling to sign informed consent. Patients that are participating in other clinical trials evaluating experimental treatments or procedures. Severe congestive heart failure (LVEF on echocardiogram < 20%). Severe pulmonary hypertension (By echocardiogram, PAS >45 mmHg). Uncontrolled diabetes mellitus (HBA1C >9.5%). Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs. Patients with positive HIV1, HIV2, HTLV1, HTLV2, and RPR (syphilis). Women who are pregnant or breast feeding. Patients, based on the opinion of the investigator, should not be enrolled into this study. HBV DNA positive. If the patient is HBsAg positive or HBcAB positive, but HBV DNA negative, irrespective of his/her anti-HBS status, patient can be enrolled, but will receive preemptive therapy with Lamivudine. Patients with HBV DNA positive will not be enroll, but if turned negative with therapy can be enrolled. Patients with HBV and HCV will be followed by HBV DNA and HCV RNA levels during the trial. Any metastasis except for portal vein involvement. Patients with Child Pugh above B8. Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine). History of blood transfusion reactions. Known allergy to bovine or murine products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AlloVax Treatment<br>Intradermal injection (ID) of AlloStim(TM) (1ml) on day 4 and 7. AlloVax Treatment: ID injection of AlloSim(TM) (1 ml) followed immediately by the ID injection of CRCL (1ml) on day 11 and 14 in same location on the left arm and on day 18 and 21 in the same location on the right arm. Intravenous infusion of AlloStim(TM)(5ml) and a CRCL alone Intradermal injection on Day 27. | Biological: AlloVax<br>* Personalized anti-cancer vaccine<br>* Other names: AlloStim plus CRCL;Biological: CRCL<br>* Personalized anti-cancer vaccine<br>* Other names: AlloVax;Biological: AlloStim<br>* ID injections IV infusion<br>* Other names: AlloStim IV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | To assess adverse events and laboratory abnormalities associated with AlloVax | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor-Specific Immunity | Determine if AlloVax elicits detectable tumor specific immunity | 30 days | 
| Tumor Biomarker Status | Biomarker concentration will be evaluated at different time points. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cancer, tumor vaccine, immunotherapy, personalized anti-cancer vaccine, HCC