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In-Situ Therapeutic Cancer Vaccine for Refractory Liver Cancer

This study has been withdrawn prior to enrollment.
(change to ITL-022-HCC-BKK-VAX+S)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01923233
First Posted: August 15, 2013
Last Update Posted: December 8, 2015
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.
Information provided by (Responsible Party):
Immunovative Therapies, Ltd.
  Purpose
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.

Condition Intervention Phase
Hepatocellular Carcinoma Biological: AlloStim Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Feasibility Study of ALLOSTIM(TM) in Combination With Radiofrequency Ablation in Patients With Refractory Hepatocellular Carcinoma

Further study details as provided by Immunovative Therapies, Ltd.:

Primary Outcome Measures:
  • Safety [ Time Frame: baseline to 90 days ]
    Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events


Secondary Outcome Measures:
  • Tumor-Specific Immunity [ Time Frame: 90 days ]
    Determine if the in-situ vaccine elicits detectable tumor specific immunity

  • Anti-Tumor Response [ Time Frame: 90 days ]
    Determine by radiological, pathological, immunological and by tumor markers any evidence of anti-tumor immune-mediated response.


Enrollment: 0
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: InSituVax

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT01923233


Locations
Israel
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Immunovative Therapies, Ltd.
Investigators
Study Director: Michael Har-Noy Immunovative Therapies, Ltd.
  More Information

Additional Information:
Publications:

Responsible Party: Immunovative Therapies, Ltd.
ClinicalTrials.gov Identifier: NCT01923233     History of Changes
Other Study ID Numbers: ITL-017-HCC
First Submitted: August 12, 2013
First Posted: August 15, 2013
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Immunovative Therapies, Ltd.:
liver cancer
HCC
tumor vaccine
immunotherapy

Additional relevant MeSH terms:
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