ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 12 for:    allostim

An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects

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.
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.

April 1, 2015
April 7, 2015
July 12, 2016
July 2016
July 2017   (Final data collection date for primary outcome measure)
To evaluate survival compared to historical controls [ Time Frame: Approximately 12 months ]
Baseline to date of death from any cause
Same as current
Complete list of historical versions of study NCT02409524 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
Same as current
  • 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
  • Tumor-Specific Immunity [ Time Frame: 30 days ]
    Immunological end-points as surrogate markers of response and/or survival
Same as current
 
An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects
Phase II Clinical Study Of An Individualized Anti-Cancer Vaccine (CRCL-ALLOVAX) in Subjects With Advanced Hepatocellular Carcinoma
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.

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

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Adult Hepatocellular Carcinoma
  • 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
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
Interventions:
  • Biological: AlloVax
  • Biological: AlloStim
  • Biological: CRCL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
August 2018
July 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT02409524
ITL-022-HCC-BKK-VAX+S
No
Not Provided
Plan to Share IPD: No
Immunovative Therapies, Ltd.
Immunovative Therapies, Ltd.
Not Provided
Principal Investigator: Wirote Lausoontornsiri, MD National Cancer Institute (NCI)
Immunovative Therapies, Ltd.
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP