In-Situ Therapeutic Cancer Vaccine for Refractory Liver Cancer

NCT01923233 | Withdrawn Phase 1 DMC

• 1 other identifier: ITL-017-HCC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an individualized anti-cancer vaccine protocol where the vaccination occurs inside of the body. To create the vaccine, a tumor lesion is selected and caused to die by a process called "Radiofrequency Ablation" or RFA. RFA causes the tumor to release its internal contents to the surrounding environment, such contents include tumor-specific antigens. Immune cells respond to the tissue damage and take-up these tumor antigens. The injection of the experimental cell drug, AlloStim(TM) into the lesion is designed to cause the responding cells to signal the immune system of the danger of the tumor, creating tumor-specific immunity.

Conditions

Hepatocellular Carcinoma

Keywords

liver cancer; HCC; tumor vaccine; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Safety

  Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events

  baseline to 90 days

Secondary Outcomes (2)

• Tumor-Specific Immunity

  90 days

• Anti-Tumor Response

  90 days

Study Arms (1)

Treatment

EXPERIMENTAL

Intradermal AlloStim(TM) (1ml) on day 0 and 3 in same location Intradermal AlloStim(TM) (1ml) on day 7 and day 10 in same location Radiofrequency ablation on day 14 followed by intralesional AlloStim (3ml) Intralesional AlloStim(TM)(3ml) on day 17 in same ablated lesion Intravenous AlloStim(TM)(5ml) on days 21, 49 and 78

Biological: AlloStim

Interventions

AlloStim BIOLOGICAL

allogeneic Th1 memory cell with CD3/CD28-coated microbeads attached.

Also known as: InSituVax

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 for or failed any HCC treatment.

You may not qualify if:

• 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.
• Subjects with positive HIV.
• Women who are pregnant or breast feeding.
• Patient, based on the opinion of the investigator, should not be enrolled into this study.
• HBsAg positive or HBV DNA positive.
• If the patient is HBcAB positive but HBsAG negative, irrespective of his anti HBS status, he can be enrolled but will receive preemptive therapy with Lamivudine.
• Any metastasis except for portal vein involvement.
• Subjects with Child Pugh above B8.
• Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).

Sponsors & Collaborators

• Mirror Biologics, Inc.: lead

Study Sites (1)

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

Location

Related 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, tumour-derived chaperone-rich cell lysate (CRCL) vaccine. Int J Hyperthermia. 2013 Aug;29(5):390-8. doi: 10.3109/02656736.2013.800997. Epub 2013 Jun 20.

  PMID: 23786302 BACKGROUND

• 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 CRCL's unique structure: CRCL vaccine proteome leads to unique structure. Int J Hyperthermia. 2013 Sep;29(6):520-7. doi: 10.3109/02656736.2013.796529. Epub 2013 Jun 4.

  PMID: 23734882 BACKGROUND

• 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-gamma-dependent mechanism. J Immunol. 2011 Dec 15;187(12):6310-7. doi: 10.4049/jimmunol.1101812. Epub 2011 Nov 9.

  PMID: 22075702 BACKGROUND

• 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 treat leukemia. Blood. 2011 Feb 3;117(5):1555-64. doi: 10.1182/blood-2010-06-288621. Epub 2010 Dec 1.

  PMID: 21123824 BACKGROUND

• 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. Epub 2008 Oct 1.

  PMID: 18834631 BACKGROUND

• Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.

  PMID: 18054441 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Michael Har-Noy

  Mirror Biologics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 15, 2013
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 22, 2020

Record last verified: 2015-12

Locations

IL (1)