An Individualized Anti-Cancer Vaccine Study in Patients With HCC

January 17, 2020 updated by: Immunovative Therapies, Ltd.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hebrew University-Hadassah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AlloVax Treatment
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
Personalized anti-cancer vaccine
Other Names:
  • AlloStim plus CRCL
Biological: CRCL
Personalized anti-cancer vaccine
Other Names:
  • Chaperone Rich Cell Lysate
  • AlloVax
Biological: AlloStim
ID injections IV infusion
Other Names:
  • AlloStim ID
  • AlloStim IV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Tumor Response
Time Frame: 30 days
To determine if there are any evidence of anti-tumor immune-mediated response by radiological and pathological changes.
30 days
Overall Survival (OS)
Time Frame: approximately 12 months
Baseline to date of death from any cause
approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunovative Therapies, Ltd.

Investigators

  • Study Director: Yaron Ilan, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITL-019-HCC-VAX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on AlloVax

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe