An Individualized Anti-Cancer Vaccine Study in Patients With HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects

NCT02409524

Advanced Adult Hepatocellular Carcinoma

COMPLETED PHASE2

In-Situ Therapeutic Cancer Vaccine for Refractory Liver Cancer

NCT01923233

Hepatocellular Carcinoma

WITHDRAWN PHASE1/PHASE2

Immunotherapy for Advanced Liver Cancer

NCT05033522

Hepatocellular Carcinoma

SUSPENDED PHASE2/PHASE3

A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC)

NCT02859324

Carcinoma, Hepatocellular

COMPLETED PHASE1/PHASE2

A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

NCT06600321

Advanced Hepatocellular Carcinoma Metastatic Hepatocellular Carcinoma

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AlloVax Treatment

Intradermal injection (ID) of AlloStim(TM) (1ml) on day 4 and 7. AlloVax Treatment: ID injection of AlloSim(TM) (1 ml) followed immediately by the ID injection of CRCL (1ml) on day 11 and 14 in same location on the left arm and on day 18 and 21 in the same location on the right arm. Intravenous infusion of AlloStim(TM)(5ml) and a CRCL alone Intradermal injection on Day 27.

Group Type EXPERIMENTAL

AlloVax

Intervention Type BIOLOGICAL

Personalized anti-cancer vaccine

CRCL

Intervention Type BIOLOGICAL

Personalized anti-cancer vaccine

AlloStim

Intervention Type BIOLOGICAL

ID injections IV infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AlloVax

Personalized anti-cancer vaccine

Intervention Type BIOLOGICAL

CRCL

Personalized anti-cancer vaccine

Intervention Type BIOLOGICAL

AlloStim

ID injections IV infusion

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AlloStim plus CRCL Chaperone Rich Cell Lysate AlloVax AlloStim ID AlloStim IV

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No