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An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects

Primary Purpose

Advanced Adult Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
AlloVax
AlloStim
CRCL
Sponsored by
Immunovative Therapies, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Adult Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Males and females who are at least 18 years of age at time of enrollment
  2. Histologically confirmed hepatocellular carcinoma with or without positive HBV and/or HCV, not candidate for local regional intervention
  3. Minimum of 90 days of sorafenib treatment or ineligible for sorafenib
  4. Child-Pugh Stage A-B (score ≥ 5 and ≤ 9)
  5. Performance status: ECOG < 2 with no deterioration over the previous 2 weeks
  6. Measurable disease (for mRECIST)
  7. Lesion amenable for percutaneous tumor harvest and follow up biopsy

  8. Adequate bone marrow, liver and renal function as assessed by the following:

    • Hemoglobin > 10.0 g/dl
    • Absolute neutrophil count (ANC) > 1,500/mm3
    • Platelet count > 75,000/μl
    • ALT and AST < 2.5 x ULN
    • Alkaline phosphatase < 4 x ULN
    • Serum creatinine < 1.5
  9. Women of child-bearing potential: negative pregnancy test
  10. Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product
  11. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate

Exclusion criteria:

  1. Severe ascites, massive or uncontrolled (+3 on Child-Pugh calculator)
  2. Severe encephalopathy, uncontrolled (+3 on Child-Pugh calculator)
  3. INR > 1.5
  4. Participation in another clinical trial evaluating experimental treatments or procedures or receiving medication/treatment for HCC other than sorafenib
  5. Any autoimmune disorder
  6. Any clinical condition requiring systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry
  7. HIV positive or syphilis
  8. History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) or uncontrolled hypertension
  9. Active clinically serious infections (> grade 2 NCI-CTCAE version 4.0)
  10. History of organ or tissue allograft
  11. Advanced liver cirrhosis
  12. Interferon or thalidomide within 1 month prior to signing informed consent
  13. Uncontrolled concurrent serious medical or psychiatric illness
  14. Clinically apparent central nervous system metastases or carcinomatous meningitis
  15. History of blood transfusion reactions
  16. Known allergy to murine monoclonal antibodies or bovine products or cow milk

Sites / Locations

  • National Cancer Institute of Thailand Address: 268/1 Rama Rd. Ratchathewi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

The treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject

Outcomes

Primary Outcome Measures

To evaluate survival compared to historical controls
Baseline to date of death from any cause

Secondary Outcome Measures

To assess AFP as surrogate end-point for response and/or survival
Biomarker concentration will be evaluated at different time points
To assess mRECIST as surrogate end-point for response and/or survival
Objective tumor responses by mRECIST will be compared with OS
To evaluate safety in advanced HCC (adverse events)
Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events

Full Information

First Posted
April 1, 2015
Last Updated
January 17, 2020
Sponsor
Immunovative Therapies, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02409524
Brief Title
An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects
Official Title
Phase IIA Clinical Study Of An Individualized Anti-Cancer Vaccine (CRCL-ALLOVAX) in Subjects With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunovative Therapies, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, single site, Phase IIA clinical trial to investigate the safety and efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients.
Detailed Description
Hepatocellular carcinoma (HCC) or primary liver cancer is the third leading cause of cancer death worldwide. It accounts for 90% of all liver cancers. More than 80% of patients present with advanced or unresectable disease. For patients with vascular invasion and/or metastases, the only approved therapy that offers a survival advantage is Sorafenib (Nexavar®). While palliative systemic chemotherapy other than Sorafenib is sometimes offered for HCC, there is no evidence that any chemotherapy has any meaningful therapeutic benefit, especially in overall survival. Subjects in the current study will either have completed at least 90 days of sorafenib treatment or are not able to receive sorafenib due to intolerability or unable to afford. Subjects will continue sorafenib as tolerated while receiving experimental therapy. The experimental dosing schedule has four segments: (1) priming, which consists of intradermal AlloStim alone; (2) vaccination, which consists of intradermal dosing of AlloStim+CRCL; (3) activation, which consists of an intravenous infusion of AlloStim; and (4) booster, which consists of monthly intradermal injections of CRCL alone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Adult Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
The treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject
Intervention Type
Biological
Intervention Name(s)
AlloVax
Other Intervention Name(s)
CRCL and AlloStim
Intervention Description
Personalized anti-cancer vaccine (injection of AlloStim followed immediately by the injection of CRCL)
Intervention Type
Biological
Intervention Name(s)
AlloStim
Other Intervention Name(s)
AlloStim ID, AlloStim IV
Intervention Description
AlloStim (ID) injection AlloStim (IV) infusion
Intervention Type
Biological
Intervention Name(s)
CRCL
Other Intervention Name(s)
Chaperone Rich Cell Lysate
Intervention Description
Autologous tumor-derived chaperone protein mixture
Primary Outcome Measure Information:
Title
To evaluate survival compared to historical controls
Description
Baseline to date of death from any cause
Time Frame
Approximately 12 months
Secondary Outcome Measure Information:
Title
To assess AFP as surrogate end-point for response and/or survival
Description
Biomarker concentration will be evaluated at different time points
Time Frame
Approximately 6 months
Title
To assess mRECIST as surrogate end-point for response and/or survival
Description
Objective tumor responses by mRECIST will be compared with OS
Time Frame
Approximately 6 months
Title
To evaluate safety in advanced HCC (adverse events)
Description
Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events
Time Frame
Approximately 6 months
Other Pre-specified Outcome Measures:
Title
Anti-Tumor Response
Description
Correlation of radiographic tumor burden assessment (mRECIST) with actual tumor burden determined by histological examination of biopsy samples
Time Frame
30 days
Title
Tumor-Specific Immunity
Description
Immunological end-points as surrogate markers of response and/or survival
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Males and females who are at least 18 years of age at time of enrollment Histologically confirmed hepatocellular carcinoma with or without positive HBV and/or HCV, not candidate for local regional intervention Minimum of 90 days of sorafenib treatment or ineligible for sorafenib Child-Pugh Stage A-B (score ≥ 5 and ≤ 9) Performance status: ECOG < 2 with no deterioration over the previous 2 weeks Measurable disease (for mRECIST) Lesion amenable for percutaneous tumor harvest and follow up biopsy Adequate bone marrow, liver and renal function as assessed by the following: Hemoglobin > 10.0 g/dl Absolute neutrophil count (ANC) > 1,500/mm3 Platelet count > 75,000/μl ALT and AST < 2.5 x ULN Alkaline phosphatase < 4 x ULN Serum creatinine < 1.5 Women of child-bearing potential: negative pregnancy test Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate Exclusion criteria: Severe ascites, massive or uncontrolled (+3 on Child-Pugh calculator) Severe encephalopathy, uncontrolled (+3 on Child-Pugh calculator) INR > 1.5 Participation in another clinical trial evaluating experimental treatments or procedures or receiving medication/treatment for HCC other than sorafenib Any autoimmune disorder Any clinical condition requiring systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry HIV positive or syphilis History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) or uncontrolled hypertension Active clinically serious infections (> grade 2 NCI-CTCAE version 4.0) History of organ or tissue allograft Advanced liver cirrhosis Interferon or thalidomide within 1 month prior to signing informed consent Uncontrolled concurrent serious medical or psychiatric illness Clinically apparent central nervous system metastases or carcinomatous meningitis History of blood transfusion reactions Known allergy to murine monoclonal antibodies or bovine products or cow milk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wirote Lausoontornsiri, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute of Thailand Address: 268/1 Rama Rd. Ratchathewi
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects

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