In-Situ Therapeutic Cancer Vaccine for Refractory Liver Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Immunovative Therapies, Ltd.
Sponsor:
Information provided by (Responsible Party):
Immunovative Therapies, Ltd.
ClinicalTrials.gov Identifier:
NCT01923233
First received: August 12, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Feasibility Study of ALLOSTIM(TM) in Combination With Radiofrequency Ablation in Patients Wwith Refractory Hepatocellular Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety [ Time Frame: baseline to 90 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Determine if the in-situ vaccine elicits detectable tumor specific immunity

  • Anti-Tumor Response [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Determine by radiological, pathological, immunological and by tumor markers any evidence of anti-tumor immune-mediated response.


Estimated Enrollment: 10
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923233

Contacts
Contact: Tova Nesher +97226777547 tovaN@hadassah.org.il

Locations
Israel
Hadassah-Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel
Sponsors and Collaborators
Immunovative Therapies, Ltd.
Investigators
Study Director: Yaron Ilan, MD Hadassah Medical Organization
Principal Investigator: Liat Applebaum, MD Hadassah Medical Organization
Principal Investigator: Saleh Daher, MD Hadassah Medical Center
Principal Investigator: Ariel Drori, MD Hadassah Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Immunovative Therapies, Ltd.
ClinicalTrials.gov Identifier: NCT01923233     History of Changes
Other Study ID Numbers: ITL-017-HCC
Study First Received: August 12, 2013
Last Updated: August 12, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 23, 2014