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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02409524
Other study ID # ITL-022-HCC-BKK-VAX+S
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2016
Est. completion date March 2019

Study information

Verified date November 2017
Source Immunovative Therapies, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 2019
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AlloVax
Personalized anti-cancer vaccine (injection of AlloStim followed immediately by the injection of CRCL)
AlloStim
AlloStim (ID) injection AlloStim (IV) infusion
CRCL
Autologous tumor-derived chaperone protein mixture

Locations

Country Name City State
Thailand National Cancer Institute of Thailand Address: 268/1 Rama Rd. Ratchathewi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Immunovative Therapies, Ltd.

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Other Anti-Tumor Response Correlation of radiographic tumor burden assessment (mRECIST) with actual tumor burden determined by histological examination of biopsy samples 30 days
Other Tumor-Specific Immunity Immunological end-points as surrogate markers of response and/or survival 30 days
Primary To evaluate survival compared to historical controls Baseline to date of death from any cause Approximately 12 months
Secondary To assess AFP as surrogate end-point for response and/or survival Biomarker concentration will be evaluated at different time points Approximately 6 months
Secondary To assess mRECIST as surrogate end-point for response and/or survival Objective tumor responses by mRECIST will be compared with OS Approximately 6 months
Secondary 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 Approximately 6 months
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