Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck

NCT01998542 | Completed Phase 2 DMC

• 1 other identifier: ITL-010-HNC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and tumor debulking efficacy of personalized anti-cancer vaccine AlloVax(TM) in Subjects with confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who cannot be treated with surgery, chemotherapy or radiation. 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 CRCL and AlloStim(TM) is designed to provide cross-reactivity of alloantigen specific recognition with tumor-specific recognition. All the key components necessary to develop tumor-specific immunity by creating the inflammatory environment necessary to overcome the HNC immunosuppressive environment, breaking tumor immune tolerance, and provision of specific HNC antigens for generation of a specific adaptive anti-tumor response.

Conditions

Cancer of Head and Neck; Squamous Cell Carcinoma of the Head and Neck

Keywords

Head and neck cancers; tumor vaccine; immunotherapy; personalized anti-cancer vaccine

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  Tumor response evaluation by clinical exam including photographs of visible tumor lesions on head, neck and/or tongue (endoscopic) and by CT scan assessment for change in target lesion tumor volume (TV). TV is defined as the volume occupied by macroscopic visible target lesion in two longest cross-sectional diameters.

  baseline, every 28 days for 5 months (CT scan confirmation at baseline and day 90 and day 150)

Secondary Outcomes (2)

• Anti-tumor immune response

  baseline, 30 days after the last dose

• Anti-Tumor Response

  baseline and 30 days after the last dose

Study Arms (1)

AlloStim+CRCL

EXPERIMENTAL

AlloStim priming followed by AlloStim+CRCL priming and AlloStim IV. 3 cycles

Biological: AlloVax; Biological: CRCL; Biological: AlloStim

Interventions

AlloVax BIOLOGICAL

Personalized anti-cancer vaccine with AlloStim(TM) and CRCL

Also known as: CRCL and AlloStim

AlloStim+CRCL

CRCL BIOLOGICAL

autologous tumor-derived chaperone protein mixture

Also known as: Chaperone Rich Cell Lysate, CRCL injection

AlloStim+CRCL

AlloStim BIOLOGICAL

AlloStim (ID) injection AlloStim (IV) infusion

Also known as: AlloStim ID, AlloStim IV

AlloStim+CRCL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and female patients aged 18 to 70 years old, inclusive, at screening visit.
• Patients with histopatholologically or cytologically confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) that is incurable with surgery, chemotherapy or radiation. No nasopharyngeal primaries.
• Patients must have a tumor safely accessable for biopsy resulting in a minimum of 0.1 g of tumor sample for CRCL processing.
• Patients must have visible external tumors measurable with at least one lesion deemed to be safely accessible for serial biopsy.
• ECOG ≤2.
• The result of screening test were in the criteria:
• Adequate organ function including:
• A. Marrow:
• WBC \>3000/mm3
• Platelets \>100,000/mm3.
• Absolute neutrophil count ≥ 1,500/mm³
• Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
• B. Hepatic:
• Serum Total bilirubin \< 2 x ULN mg/dL,
• ALT (SGPT) / AST (SGOT) ≤3 x upper limit of normal (ULN).

You may not qualify if:

• Clinical evidence or radiological evidence of nasopharyngeal primaries.
• Clinical evidence or radiological evidence of brain metastasis.
• History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs.
• Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis).
• Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
• Clinical requirement for systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia
• All infections must be resolved and the patient must remain a febrile for seven days prior to being placed in the study.
• History of blood transfusion reactions.
• Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation.
• Pregnant or breast feeding.
• The patient will discontinuation from the participation in the study:
• Less than 12 doses of CRCL able to be produced
• Tumor sample for CRCL processing contains less than 80% tumor.

Sponsors & Collaborators

• Mirror Biologics, Inc.: lead

Study Sites (1)

National Cancer Institute of Thailand

Bangkok, Thailand

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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Related Links

• Cancer
• Head and Neck Cancer

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Michael Har-Noy, Dr.

  Mirror Biologics, Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: 12 subjects with externally measurable disease

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 29, 2013
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 23, 2020

Record last verified: 2016-08

Locations

TH (1)