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Cancer of Head and NeckPhase 2HNCNCT01998542

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

A Phase 2 study testing AlloVax, CRCL and AlloStim in people with Cancer of Head and Neck and Squamous Cell Carcinoma of the Head and Neck, run by Mirror Biologics, Inc. at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
AlloVax, CRCL and AlloStim
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteThailand
Study dates
Jan 2016to Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 6.1 Adequate organ function including:
  • Marrow:
  • WBC >3000/mm3
  • Platelets >100,000/mm3.
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
  • Hepatic:
  • Serum Total bilirubin < 2 x ULN mg/dL,
  • ALT (SGPT) / AST (SGOT) ≤3 x upper limit of normal (ULN).
  • Renal:
  • Serum creatinine (SCR) <2.0 x ULN, or
  • Creatinine clearance (CCR) >30 mL/min.
  • 6.2 All patients have a pre-study echocardiogram without significant abnormalities or Ejection fraction >50%.
  • 6.3 All patients must be screened to be negative for HIV1, HIV2, HTLVI, HTLVII, HBV, HCV and RPR (syphilis).
  • 6.4 Women of child-bearing potential must have a negative urine or serum pregnancy test result within 72 hours prior to the start of study drug administration.
  • All patients of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product.
  • Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • National Cancer Institute of Thailand

    Bangkok

Other trials in Thailand

About this study

Official title: Phase II Study Designed To Evaluate Safety and Tumor Debulking Mechanism of an Individualized Cancer Vaccine (AllovaxTM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck.

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.

Read the detailed description

This is a Phase II study following up on a previous Phase I/II study in chemotherapy refractory metastatic disease with <90 day survival expectancy. In the Phase I/II study all patients progressed using RECIST criteria. However, 11/42 (26%) were alive at 1yr and 9/42 (21%) alive at 2 yr. Therefore, CT scans did not correlate with clinical presentation and "pseudo-progression" was suspected. This study was designed to select subjects with visible tumor burden on the head, neck or tongue that could be measured and photographed so as not to rely solely on CT scans to determine anti-tumor debulking efficacy. Subjects are initially primed with intradermal AlloStim(TM) injections creating systemic anti-allo-specific cellular immunity. Tumor biopsy samples taken prior to dosing were processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine containing enriched heat shock proteins which are believed to chaperone tumor-specific neoantigens . AlloStim(TM) was then injected with CRCL into primed subjects to create tumor-specific cellular immunity. Subsequently, subjects are infused with intravenous AlloStim(TM) to cause extravasation of memory cells to the tumor lesions. The protocol including intradermal AlloStim(TM) day 0, 3, 7, 10. Intradermal AlloStim(TM)+CRCL on days 14, 17, 21, 24. Intravenous AlloStim(TM) day 28. This experimental treatment schedule will continue for 3 cycles.

Being tested
AlloVax, CRCL, AlloStim
Keywords
Head and neck cancers, tumor vaccine, immunotherapy, personalized anti-cancer vaccine
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlloVaxBiological

    Also called CRCL and AlloStim

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

  • CRCLBiological

    Also called Chaperone Rich Cell Lysate, CRCL injection

    autologous tumor-derived chaperone protein mixture

  • AlloStimBiological

    Also called AlloStim ID, AlloStim IV

    AlloStim (ID) injection AlloStim (IV) infusion

Study groups in NCT01998542
Study groupRoleWhat they receive
AlloStim+CRCLExperimentalAlloStim priming followed by AlloStim+CRCL priming and AlloStim IV. 3 cycles
Receives: Biological: AlloVax; Biological: CRCL; Biological: AlloStim

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Anti-tumor immune response

    change in tumor pathology and immune cell inflitration

    Measured: baseline, 30 days after the last dose

  2. Anti-Tumor Response

    expression of CTLA4.

    Measured: baseline and 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2013 (estimated)
  2. Study startJan 2016
  3. Primary completion1 Jun 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
12 subjects with externally measurable disease
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01998542
Sponsor's protocol ID
ITL-010-HNC
Acronym
HNC
Status last verified
Aug 2016
First submitted
21 Nov 2013
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23786302

  • 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.

    PubMed 23734882

  • 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.

    PubMed 22075702

  • 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.

    PubMed 21123824

  • 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.

    PubMed 18834631

  • 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.

    PubMed 18054441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AlloVax, CRCL and AlloStim in people with Cancer of Head and Neck and Squamous Cell Carcinoma of the Head and Neck, run by Mirror Biologics, Inc. at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Response (time frame: baseline, every 28 days for 5 months (CT scan confirmation at baseline and day 90 and day 150)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01998542, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.

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