In-Situ Therapeutic Cancer Vaccine for Refractory Liver Cancer

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

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
        • Hadassah-Hebrew University 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:

  1. Any patients with a diagnosis of HCC based on histology or the current accepted radiological measures.
  2. Age > 18 years.
  3. Patient has an MRI or CT result (positive for HCC) up to 3 months prior to recruitment.
  4. AFP >30.
  5. Patient who is not eligible for or failed any HCC treatment.

Exclusion Criteria:

  1. Patient is unable or unwilling to sign informed consent.
  2. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
  3. Severe congestive heart failure (LVEF on echocardiogram < 20%).
  4. Severe pulmonary hypertension (By echocardiogram, PAS >45 mmHg).
  5. Uncontrolled diabetes mellitus (HBA1C >9.5%).
  6. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
  7. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
  8. Subjects with positive HIV.
  9. Women who are pregnant or breast feeding.
  10. Patient, based on the opinion of the investigator, should not be enrolled into this study.
  11. HBsAg positive or HBV DNA positive.
  12. 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.
  13. Any metastasis except for portal vein involvement.
  14. Subjects with Child Pugh above B8.
  15. Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
  16. History of blood transfusion reactions.
  17. 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: Treatment
Intradermal 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
Biological: AlloStim
allogeneic Th1 memory cell with CD3/CD28-coated microbeads attached.
Other Names:
  • InSituVax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: baseline to 90 days
Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events
baseline to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor-Specific Immunity
Time Frame: 90 days
Determine if the in-situ vaccine elicits detectable tumor specific immunity
90 days
Anti-Tumor Response
Time Frame: 90 days
Determine by radiological, pathological, immunological and by tumor markers any evidence of anti-tumor immune-mediated response.
90 days

Collaborators and Investigators

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

Sponsor

Immunovative Therapies, Ltd.

Investigators

  • Study Director: Michael Har-Noy, Immunovative Therapies, Ltd.

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

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 (Actual)

November 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 15, 2013

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITL-017-HCC

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.

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