NCT01995227

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2013

Typical duration for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 22, 2020

Status Verified

April 1, 2015

Enrollment Period

4.2 years

First QC Date

November 18, 2013

Last Update Submit

January 17, 2020

Conditions

Hepatocellular Carcinoma

Keywords

liver cancerHCCtumor vaccineimmunotherapypersonalized anti-cancer vaccine

Outcome Measures

Primary Outcomes (1)

  • Safety

    To assess adverse events and laboratory abnormalities associated with AlloVax

    30 days

Secondary Outcomes (2)

  • Tumor-Specific Immunity

    30 days

  • Tumor Biomarker Status

    30 days

Other Outcomes (2)

  • Anti-Tumor Response

    30 days

  • Overall Survival (OS)

    approximately 12 months

Study Arms (1)

AlloVax Treatment

EXPERIMENTAL

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: AlloVaxBiological: CRCLBiological: AlloStim

Interventions

AlloVaxBIOLOGICAL

Personalized anti-cancer vaccine

Also known as: AlloStim plus CRCL
AlloVax Treatment
CRCLBIOLOGICAL

Personalized anti-cancer vaccine

Also known as: Chaperone Rich Cell Lysate, AlloVax
AlloVax Treatment
AlloStimBIOLOGICAL

ID injections IV infusion

Also known as: AlloStim ID, AlloStim IV
AlloVax Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew University-Hadassah Medical Center

Jerusalem, Israel

Location

Related Publications (6)

  • 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.

    PMID: 23786302RESULT

  • 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.

    PMID: 23734882RESULT

  • 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.

    PMID: 22075702RESULT

  • 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.

    PMID: 21123824RESULT

  • 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.

    PMID: 18834631RESULT

  • 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.

    PMID: 18565579RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Yaron Ilan, MD

    Hadassah Medical Organization

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 26, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2018

Study Completion

July 1, 2018

Last Updated

January 22, 2020

Record last verified: 2015-04

Locations

IL(1)