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An Individualized Anti-Cancer Vaccine Study in Patients With HCC

Primary Purpose

Hepatocellular Carcinoma

Status

Withdrawn

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

AlloVax

CRCL

AlloStim

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring liver cancer, HCC, tumor vaccine, immunotherapy, personalized anti-cancer vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hebrew University-Hadassah Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AlloVax Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety

To assess adverse events and laboratory abnormalities associated with AlloVax

Secondary Outcome Measures

Tumor-Specific Immunity

Determine if AlloVax elicits detectable tumor specific immunity

Tumor Biomarker Status

Biomarker concentration will be evaluated at different time points.

Full Information

NCT ID

NCT01995227

First Posted

November 18, 2013

Last Updated

January 17, 2020

Sponsor

Immunovative Therapies, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01995227

Brief Title

An Individualized Anti-Cancer Vaccine Study in Patients With HCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Study site change to Thailand

Study Start Date

December 2013 (undefined)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immunovative Therapies, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

liver cancer, HCC, tumor vaccine, immunotherapy, personalized anti-cancer vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AlloVax Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

AlloVax

Other Intervention Name(s)

AlloStim plus CRCL

Intervention Description

Personalized anti-cancer vaccine

Intervention Type

Biological

Intervention Name(s)

CRCL

Other Intervention Name(s)

Chaperone Rich Cell Lysate, AlloVax

Intervention Description

Personalized anti-cancer vaccine

Intervention Type

Biological

Intervention Name(s)

AlloStim

Other Intervention Name(s)

AlloStim ID, AlloStim IV

Intervention Description

ID injections IV infusion

Primary Outcome Measure Information:

Title

Safety

Description

To assess adverse events and laboratory abnormalities associated with AlloVax

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Tumor-Specific Immunity

Description

Determine if AlloVax elicits detectable tumor specific immunity

Time Frame

30 days

Title

Tumor Biomarker Status

Description

Biomarker concentration will be evaluated at different time points.

Time Frame

30 days

Other Pre-specified Outcome Measures:

Title

Anti-Tumor Response

Description

To determine if there are any evidence of anti-tumor immune-mediated response by radiological and pathological changes.

Time Frame

30 days

Title

Overall Survival (OS)

Description

Baseline to date of death from any cause

Time Frame

approximately 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yaron Ilan, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Study Director

Facility Information:

Facility Name

Hebrew University-Hadassah Medical Center

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

23786302

Citation

Epple LM, Bemis LT, Cavanaugh RP, Skope A, Mayer-Sonnenfeld T, Frank C, Olver CS, Lencioni AM, Dusto NL, Tal A, Har-Noy M, Lillehei KO, Katsanis E, Graner MW. Prolonged remission of advanced bronchoalveolar adenocarcinoma in a dog treated with autologous, tumour-derived chaperone-rich cell lysate (CRCL) vaccine. Int J Hyperthermia. 2013 Aug;29(5):390-8. doi: 10.3109/02656736.2013.800997. Epub 2013 Jun 20.

Results Reference

result

PubMed Identifier

23734882

Citation

Mayer-Sonnenfeld T, Har-Noy M, Lillehei KO, Graner MW. Proteomic analyses of different human tumour-derived chaperone-rich cell lysate (CRCL) anti-cancer vaccines reveal antigen content and strong similarities amongst the vaccines along with a basis for CRCL's unique structure: CRCL vaccine proteome leads to unique structure. Int J Hyperthermia. 2013 Sep;29(6):520-7. doi: 10.3109/02656736.2013.796529. Epub 2013 Jun 4.

Results Reference

result

PubMed Identifier

22075702

Citation

LaCasse CJ, Janikashvili N, Larmonier CB, Alizadeh D, Hanke N, Kartchner J, Situ E, Centuori S, Har-Noy M, Bonnotte B, Katsanis E, Larmonier N. Th-1 lymphocytes induce dendritic cell tumor killing activity by an IFN-gamma-dependent mechanism. J Immunol. 2011 Dec 15;187(12):6310-7. doi: 10.4049/jimmunol.1101812. Epub 2011 Nov 9.

Results Reference

result

PubMed Identifier

21123824

Citation

Janikashvili N, LaCasse CJ, Larmonier C, Trad M, Herrell A, Bustamante S, Bonnotte B, Har-Noy M, Larmonier N, Katsanis E. Allogeneic effector/memory Th-1 cells impair FoxP3+ regulatory T lymphocytes and synergize with chaperone-rich cell lysate vaccine to treat leukemia. Blood. 2011 Feb 3;117(5):1555-64. doi: 10.1182/blood-2010-06-288621. Epub 2010 Dec 1.

Results Reference

result

PubMed Identifier

18834631

Citation

Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.

Results Reference

result

PubMed Identifier

18565579

Citation

Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.

Results Reference

result

Links:

URL

http://www.nlm.nih.gov/medlineplus/livercancer.html

Description

Liver Cancer

Learn more about this trial

An Individualized Anti-Cancer Vaccine Study in Patients With HCC

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