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An Individualized Anti-Cancer Vaccine Study in Patients With HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995227
Recruitment Status : Withdrawn (Study site change to Thailand)
First Posted : November 26, 2013
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Immunovative Therapies, Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Biological: AlloVax Biological: CRCL Biological: AlloStim Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Individualized Anti-Cancer Vaccine (AlloVaxTM) Study in Patients With Refractory Hepatocellular Carcinoma (HCC)
Study Start Date : December 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Safety [ Time Frame: 30 days ]
    To assess adverse events and laboratory abnormalities associated with AlloVax


Secondary Outcome Measures :
  1. Tumor-Specific Immunity [ Time Frame: 30 days ]
    Determine if AlloVax elicits detectable tumor specific immunity

  2. Tumor Biomarker Status [ Time Frame: 30 days ]
    Biomarker concentration will be evaluated at different time points.


Other Outcome Measures:
  1. 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.

  2. Overall Survival (OS) [ Time Frame: approximately 12 months ]
    Baseline to date of death from any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995227


Locations
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Israel
Hebrew University-Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Immunovative Therapies, Ltd.
Investigators
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Study Director: Yaron Ilan, MD Hadassah Medical Center
Additional Information:
Publications of Results:

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Responsible Party: Immunovative Therapies, Ltd.
ClinicalTrials.gov Identifier: NCT01995227    
Other Study ID Numbers: ITL-019-HCC-VAX
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: April 2015
Keywords provided by Immunovative Therapies, Ltd.:
liver cancer
HCC
tumor vaccine
immunotherapy
personalized anti-cancer vaccine
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases