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

January 21, 2020 updated by: Immunovative Therapies, Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • National Cancer Institute of Thailand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult males and female patients aged 18 to 70 years old, inclusive, at screening visit.
  2. 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.
  3. Patients must have a tumor safely accessable for biopsy resulting in a minimum of 0.1 g of tumor sample for CRCL processing.
  4. Patients must have visible external tumors measurable with at least one lesion deemed to be safely accessible for serial biopsy.
  5. ECOG ≤2.

  6. The result of screening test were in the criteria:

    6.1 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).

    C. 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.

  7. 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.
  8. 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.

Exclusion Criteria:

  1. Clinical evidence or radiological evidence of nasopharyngeal primaries.
  2. Clinical evidence or radiological evidence of brain metastasis.
  3. History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs.
  4. Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis).
  5. Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
  6. Clinical requirement for systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry.
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia
  8. All infections must be resolved and the patient must remain a febrile for seven days prior to being placed in the study.
  9. History of blood transfusion reactions.
  10. Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation.
  11. Pregnant or breast feeding.

The patient will discontinuation from the participation in the study:

  1. Less than 12 doses of CRCL able to be produced
  2. Tumor sample for CRCL processing contains less than 80% tumor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AlloStim+CRCL
AlloStim priming followed by AlloStim+CRCL priming and AlloStim IV. 3 cycles
Biological: AlloVax
Personalized anti-cancer vaccine with AlloStim(TM) and CRCL
Other Names:
  • CRCL and AlloStim
Biological: CRCL
autologous tumor-derived chaperone protein mixture
Other Names:
  • Chaperone Rich Cell Lysate
  • CRCL injection
Biological: AlloStim
AlloStim (ID) injection AlloStim (IV) infusion
Other Names:
  • AlloStim ID
  • AlloStim IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Response
Time Frame: baseline, every 28 days for 5 months (CT scan confirmation at baseline and day 90 and day 150)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-tumor immune response
Time Frame: baseline, 30 days after the last dose
change in tumor pathology and immune cell inflitration
baseline, 30 days after the last dose
Anti-Tumor Response
Time Frame: baseline and 30 days after the last dose
expression of CTLA4.
baseline and 30 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunovative Therapies, Ltd.

Investigators

  • Study Director: Michael Har-Noy, Dr., Immunovative Therapies, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 25, 2013

First Posted (ESTIMATE)

November 29, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITL-010-HNC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Squamous Cell Carcinoma of the Head and Neck

Clinical Trials on AlloVax

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe