An Individualized Anti-Cancer Vaccine Study in Patients With HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

An Individualized Anti-Cancer Vaccine (AlloVaxTM) Study in Patients With Refractory Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01995227
• Other study ID #: ITL-019-HCC-VAX
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: December 2013
• Est. completion date: July 2018

Study information

• Verified date: April 2015
• Source: Immunovative Therapies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and the immunological, radiological, and pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients with refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC treatments or have failed all approved HCC treatments. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of these two components provides a vaccine designed to bring out an immune response capable of finding and killing the tumor cells.

Description:

All accrued subjects will undergo tumor harvest procedure. The tumor samples will be processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine. This study consists of three phases: priming phase, vaccination phase, and activation phase. The priming phase involves intradermal injections of AlloStim(TM). The aim of this phase is to increase the titer of Th1 immune cells in circulation. The vaccination phase involves the intradermal injections of AlloSim(TM) immediately followed by the intradermal injections of CRCL. This phase is designed to elicit tumor-specific immunity. The activation phase involves intravenous infusion of AlloStim(TM). This phase is designed to activate memory cells and NK cells and cause them to extravasate and traffic to tumor sites.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any Patients with a diagnosis of HCC based on histology or the current accepted radiological measures.

• Age > 18 years.

• Patient has an MRI or CT result (positive for HCC) up to 3 months prior to recruitment.

• AFP > 30.

• Patient who is not eligible or failed all approved HCC treatments.

Exclusion Criteria:

• Patient is unable or unwilling to sign informed consent.

• Patients that are participating in other clinical trials evaluating experimental treatments or procedures.

• Severe congestive heart failure (LVEF on echocardiogram < 20%).

• Severe pulmonary hypertension (By echocardiogram, PAS >45 mmHg).

• Uncontrolled diabetes mellitus (HBA1C >9.5%).

• Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.

• Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.

• Patients with positive HIV1, HIV2, HTLV1, HTLV2, and RPR (syphilis).

• Women who are pregnant or breast feeding.

• Patients, based on the opinion of the investigator, should not be enrolled into this study.

• HBV DNA positive.

• If the patient is HBsAg positive or HBcAB positive, but HBV DNA negative, irrespective of his/her anti-HBS status, patient can be enrolled, but will receive preemptive therapy with Lamivudine.

• Patients with HBV DNA positive will not be enroll, but if turned negative with therapy can be enrolled. Patients with HBV and HCV will be followed by HBV DNA and HCV RNA levels during the trial.

• Any metastasis except for portal vein involvement.

• Patients with Child Pugh above B8.

• Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).

• History of blood transfusion reactions.

• Known allergy to bovine or murine products

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• AlloVax
Personalized anti-cancer vaccine
• CRCL
Personalized anti-cancer vaccine
• AlloStim
ID injections IV infusion

Locations

Country	Name	City	State
Israel	Hebrew University-Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Immunovative Therapies, Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Epple LM, Bemis LT, Cavanaugh RP, Skope A, Mayer-Sonnenfeld T, Frank C, Olver CS, Lencioni AM, Dusto NL, Tal A, Har-Noy M, Lillehei KO, Katsanis E, Graner MW. Prolonged remission of advanced bronchoalveolar adenocarcinoma in a dog treated with autologous, — View Citation

Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. — View Citation

Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007 — View Citation

Janikashvili N, LaCasse CJ, Larmonier C, Trad M, Herrell A, Bustamante S, Bonnotte B, Har-Noy M, Larmonier N, Katsanis E. Allogeneic effector/memory Th-1 cells impair FoxP3+ regulatory T lymphocytes and synergize with chaperone-rich cell lysate vaccine to — View Citation

LaCasse CJ, Janikashvili N, Larmonier CB, Alizadeh D, Hanke N, Kartchner J, Situ E, Centuori S, Har-Noy M, Bonnotte B, Katsanis E, Larmonier N. Th-1 lymphocytes induce dendritic cell tumor killing activity by an IFN-?-dependent mechanism. J Immunol. 2011 — View Citation

Mayer-Sonnenfeld T, Har-Noy M, Lillehei KO, Graner MW. Proteomic analyses of different human tumour-derived chaperone-rich cell lysate (CRCL) anti-cancer vaccines reveal antigen content and strong similarities amongst the vaccines along with a basis for C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-Tumor Response	To determine if there are any evidence of anti-tumor immune-mediated response by radiological and pathological changes.	30 days
Other	Overall Survival (OS)	Baseline to date of death from any cause	approximately 12 months
Primary	Safety	To assess adverse events and laboratory abnormalities associated with AlloVax	30 days
Secondary	Tumor-Specific Immunity	Determine if AlloVax elicits detectable tumor specific immunity	30 days
Secondary	Tumor Biomarker Status	Biomarker concentration will be evaluated at different time points.	30 days

External Links

•   Liver Cancer