NCT02409524

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 22, 2020

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

April 1, 2015

Last Update Submit

January 17, 2020

Conditions

Advanced Adult Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate survival compared to historical controls

    Baseline to date of death from any cause

    Approximately 12 months

Secondary Outcomes (3)

  • To assess AFP as surrogate end-point for response and/or survival

    Approximately 6 months

  • To assess mRECIST as surrogate end-point for response and/or survival

    Approximately 6 months

  • To evaluate safety in advanced HCC (adverse events)

    Approximately 6 months

Other Outcomes (2)

  • Anti-Tumor Response

    30 days

  • Tumor-Specific Immunity

    30 days

Study Arms (1)

Treatment

EXPERIMENTAL

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: AlloVaxBiological: AlloStimBiological: CRCL

Interventions

AlloVaxBIOLOGICAL

Personalized anti-cancer vaccine (injection of AlloStim followed immediately by the injection of CRCL)

Also known as: CRCL and AlloStim
Treatment
AlloStimBIOLOGICAL

AlloStim (ID) injection AlloStim (IV) infusion

Also known as: AlloStim ID, AlloStim IV
Treatment
CRCLBIOLOGICAL

Autologous tumor-derived chaperone protein mixture

Also known as: Chaperone Rich Cell Lysate
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females who are at least 18 years of age at time of enrollment
  • Histologically confirmed hepatocellular carcinoma with or without positive HBV and/or HCV, not candidate for local regional intervention
  • Minimum of 90 days of sorafenib treatment or ineligible for sorafenib
  • Child-Pugh Stage A-B (score ≥ 5 and ≤ 9)
  • Performance status: ECOG \< 2 with no deterioration over the previous 2 weeks
  • Measurable disease (for mRECIST)
  • Lesion amenable for percutaneous tumor harvest and follow up biopsy
  • 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
  • Women of child-bearing potential: negative pregnancy test
  • +2 more criteria

You may not qualify if:

  • Severe ascites, massive or uncontrolled (+3 on Child-Pugh calculator)
  • Severe encephalopathy, uncontrolled (+3 on Child-Pugh calculator)
  • INR \> 1.5
  • Participation in another clinical trial evaluating experimental treatments or procedures or receiving medication/treatment for HCC other than sorafenib
  • Any autoimmune disorder
  • Any clinical condition requiring systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry
  • HIV positive or syphilis
  • 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
  • Active clinically serious infections (\> grade 2 NCI-CTCAE version 4.0)
  • History of organ or tissue allograft
  • Advanced liver cirrhosis
  • Interferon or thalidomide within 1 month prior to signing informed consent
  • Uncontrolled concurrent serious medical or psychiatric illness
  • Clinically apparent central nervous system metastases or carcinomatous meningitis
  • History of blood transfusion reactions
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute of Thailand Address: 268/1 Rama Rd. Ratchathewi

Bangkok, 10400, Thailand

Location

Study Officials

  • Wirote Lausoontornsiri, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 7, 2015

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

March 1, 2019

Last Updated

January 22, 2020

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)