AzTrials
AzTrials

Hepatocellular CarcinomaPhase 1/2NCT01923233

In-Situ Therapeutic Cancer Vaccine for Refractory Liver Cancer

A Phase 1/2 study testing AlloStim in people with Hepatocellular Carcinoma, run by Mirror Biologics, Inc. at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This study is an individualized anti-cancer vaccine protocol where the vaccination occurs inside of the body. To create the vaccine, a tumor lesion is selected and caused to die by a process called "Radiofrequency Ablation" or RFA. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
AlloStim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteIsrael
Study dates
Nov 2014to Jun 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 for or failed any HCC treatment.

Who cannot join

  • 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.
Show all 17Show fewer
  • Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
  • Subjects with positive HIV.
  • Women who are pregnant or breast feeding.
  • Patient, based on the opinion of the investigator, should not be enrolled into this study.
  • HBsAg positive or HBV DNA positive.
  • If the patient is HBcAB positive but HBsAG negative, irrespective of his anti HBS status, he can be enrolled but will receive preemptive therapy with Lamivudine.
  • Any metastasis except for portal vein involvement.
  • Subjects 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Hadassah-Hebrew University Medical Center

    Jerusalem

Other trials in Israel

About this study

Official title: Phase I Feasibility Study of ALLOSTIM(TM) in Combination With Radiofrequency Ablation in Patients With Refractory Hepatocellular Carcinoma

This study is an individualized anti-cancer vaccine protocol where the vaccination occurs inside of the body. To create the vaccine, a tumor lesion is selected and caused to die by a process called "Radiofrequency Ablation" or RFA. RFA causes the tumor to release its internal contents to the surrounding environment, such contents include tumor-specific antigens. Immune cells respond to the tissue damage and take-up these tumor antigens. The injection of the experimental cell drug, AlloStim(TM) into the lesion is designed to cause the responding cells to signal the immune system of the danger of the tumor, creating tumor-specific immunity.

Read the detailed description

The protocol design has 4 steps: (1) priming; (2) vaccination, (3) activation and (4) boosting. The priming step involves intradermal injections of AlloStim(TM). This is designed to increase the circulating titer of allo-specific Th1 memory cells; the vaccination step involves percutaneous radiofrequency ablation of a single liver lesion followed immediately with an intratumoral injection of AlloStim(TM) into the ablated lesion, followed 3 days later by an additional intratumoral injection into the previously ablated lesion with AlloStim(TM). This step is designed to elicit tumor-specific Th1 immunity. The activation step involves intravenous infusions of AlloStim(TM). This step is designed to cause the activation and extravasation of circulating memory cells and the activation of innate immune cells. The booster step includes two monthly IV infusions of AlloStim(TM). This step is designed to maintain an inflammatory cytokine storm designed to counteract immune suppressor mechanisms and tumor immunoavoidance mechanisms.

Being tested
AlloStim
Keywords
liver cancer, HCC, tumor vaccine, immunotherapy
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlloStimBiological

    Also called InSituVax

    allogeneic Th1 memory cell with CD3/CD28-coated microbeads attached.

Study groups in NCT01923233
Study groupRoleWhat they receive
TreatmentExperimentalIntradermal AlloStim(TM) (1ml) on day 0 and 3 in same location Intradermal AlloStim(TM) (1ml) on day 7 and day 10 in same location Radiofrequency ablation on day 14 followed by intralesional AlloStim (3ml) Intralesional AlloStim(TM)(3ml) on day 17 in same ablated lesion Intravenous AlloStim(TM)(5ml) on days 21, 49 and 78
Receives: Biological: AlloStim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events

    Measured: baseline to 90 days

Secondary outcomes (2)

  1. Tumor-Specific Immunity

    Determine if the in-situ vaccine elicits detectable tumor specific immunity

    Measured: 90 days

  2. Anti-Tumor Response

    Determine by radiological, pathological, immunological and by tumor markers any evidence of anti-tumor immune-mediated response.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2013 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2015 (estimated)
  4. Study completionJun 2015

Why it stopped: interventional radiologist suffered stroke and unable to perform RFA procedure

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01923233
Sponsor's protocol ID
ITL-017-HCC
Status last verified
Dec 2015
First submitted
12 Aug 2013
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23786302

  • 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.

    PubMed 23734882

  • 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.

    PubMed 22075702

  • 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.

    PubMed 21123824

  • 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.

    PubMed 18834631

  • Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.

    PubMed 18054441

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AlloStim in people with Hepatocellular Carcinoma, run by Mirror Biologics, Inc. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: baseline to 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01923233, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in