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Trial record 10 of 12 for:    allostim

An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects

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ClinicalTrials.gov Identifier: NCT02409524
Recruitment Status : Unknown
Verified July 2016 by Immunovative Therapies, Ltd..
Recruitment status was:  Recruiting
First Posted : April 7, 2015
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Immunovative Therapies, Ltd.

Brief Summary:
This is an open-label, single site, Phase II clinical trial to investigate the safety and efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients after a minimum of 90 days on sorafenib.

Condition or disease Intervention/treatment Phase
Advanced Adult Hepatocellular Carcinoma Biological: AlloVax Biological: AlloStim Biological: CRCL Phase 2

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 have completed at least 90 days of sorafenib treatment. 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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study Of An Individualized Anti-Cancer Vaccine (CRCL-ALLOVAX) in Subjects With Advanced Hepatocellular Carcinoma
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: Treatment
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
Biological: AlloVax
Personalized anti-cancer vaccine (injection of AlloStim followed immediately by the injection of CRCL)
Other Name: CRCL and AlloStim

Biological: AlloStim
AlloStim (ID) injection AlloStim (IV) infusion
Other Names:
  • AlloStim ID
  • AlloStim IV

Biological: CRCL
Autologous tumor-derived chaperone protein mixture
Other Name: Chaperone Rich Cell Lysate




Primary Outcome Measures :
  1. To evaluate survival compared to historical controls [ Time Frame: Approximately 12 months ]
    Baseline to date of death from any cause


Secondary Outcome Measures :
  1. To assess AFP as surrogate end-point for response and/or survival [ Time Frame: Approximately 6 months ]
    Biomarker concentration will be evaluated at different time points

  2. To assess RECIST 1.1 as surrogate end-point for response and/or survival [ Time Frame: Approximately 6 months ]
    Objective tumor responses by RECIST will be compared with OS

  3. To evaluate safety in advanced HCC (adverse events) [ Time Frame: Approximately 6 months ]
    Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events


Other Outcome Measures:
  1. Anti-Tumor Response [ Time Frame: 30 days ]
    Correlation of radiographic tumor burden assessment (RECIST 1.1) with actual tumor burden determined by histological examination of biopsy samples

  2. Tumor-Specific Immunity [ Time Frame: 30 days ]
    Immunological end-points as surrogate markers of response and/or survival



Information from the National Library of Medicine

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

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
  3. Minimum of 90 days of sorafenib treatment and unresectable
  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 RECIST)
  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

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): NCT02409524


Contacts
Contact: Wirote Lausoontornsiri, MD +66 81-373-7690 wlausoon@yahoo.com

Locations
Thailand
National Cancer Institute of Thailand Address: 268/1 Rama Rd. Ratchathewi Recruiting
Bangkok, Thailand, 10400
Contact: Wirote Lausoontornsiri, MD    081-373-7690    wlausoon@gmail.com   
Contact: Nitiya Ritthidechratn    02-0260149    nitiya@immunovative.com   
Principal Investigator: Wirote Lausoontornsiri, MD         
Sub-Investigator: Somjin Chindavijak, MD         
Sub-Investigator: Jesada Suvikrom, MD         
Sponsors and Collaborators
Immunovative Therapies, Ltd.
Investigators
Principal Investigator: Wirote Lausoontornsiri, MD National Cancer Institute (NCI)

Responsible Party: Immunovative Therapies, Ltd.
ClinicalTrials.gov Identifier: NCT02409524     History of Changes
Other Study ID Numbers: ITL-022-HCC-BKK-VAX+S
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs