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NCT Number: NCT00210470

A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors.

The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
  • No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.
  • Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent.
  • Life Expectancy of greater than 6 months

Exclusion criteria

  • Stage IVB Squamous Cell Carcinoma
  • Use of any investigational agent within the previous 30 days
  • Uncontrolled cardiovascular disease
  • Myocardial infarction within the last 3 months
  • Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts
  • Positive for hepatitis B or C or HIV
  • Evidence of distant metastases
  • Clinical gastritis or peptic ulcer within the last 6 months
  • Stroke within the last six months

Treatment and study plan

IRX-2

Biological

IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.

Cyclophosphamide

Drug

Single i.v. injection of low-dose (300 mg/m2) on Day 1

Other names: Cytoxan, cyclophosphane

Indomethacin

Drug

21 days of oral indomethacin, 25 mg. 3 times daily

Other names: Indocin, Indocid

Zinc

Drug

21 days of zinc gluconate (65 mg) as part of an oral multivitamin

Other names: zinc gluconate

Omeprazole

Drug

21 days of 20 mg. orally

Other names: Prilosec

Primary outcomes

  1. Number of Participants With Adverse Events and Serious Adverse Events

    Time frame: Enrollment through 30 days post-surgery

    The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described.

Secondary outcomes

  1. Clinical and Histological Tumor Responses

    Time frame: On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery

    Number of participants with the specified percent change in size of target lesion is presented

  2. Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;

    Time frame: Following surgery and post-operative therapy (up to 39 days post surgery)

    Patient Tolerance of Surgery and Post-operative Adjuvant Therapy as measured by median days spent in the hospital, intensive care unit, and step down unit.

  3. Immune Competence as Measured by Skin Test Reactivity

    Time frame: At approx. 21 days, prior to surgery

    To assess measures of immune competence following administration of the IRX-2 regimen, including skin test reactivity.

  4. Disease-free Survival

    Time frame: Time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy, assessed up to 3 years; margins of resection positive for tumor will not be considered disease recurrence

    Estimate disease-free survival (DFS) (time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy, assessed up to 3 years; margins of resection positive for tumor will not be considered disease recurrence).

  5. Overall Survival

    Time frame: Time from surgery to death or confirmed recurrent or progressive disease, assessed up to 3 years

    Estimate overall survival (OS) in patients receiving the IRX-2 regimen. IRX-2 is currently being studied in an on-going Phase 2b clinical trial in patients with newly diagnosed Stage II, III, and IVA squamous cell carcinoma of the oral cavity (INSPIRE)

  6. Number of Participants With High Lymphocyte Infiltration (LI) According to the Visual Analog Scale (VAS)

    Time frame: On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery

    Immunologic response features were extracted and quantified using a VAS of 0-100 mm to provide for a more continuous variable than the 0-4+ scale that is often used to assess histological responses. The scoring was such that 100 represented the maximum for any sample and 0 represented the lack of any parameter of interest.

    See publication of Berinstein, et al., 2012 for complete details.

  7. Relationship Between Overall Survival (OS) and Immune Competence (Lymphocyte Infiltration, LI) in Participants With High LI and Low LI

    Time frame: At time of surgery, after treatment with IRX-2 Regimen, assessed up to 5 years

    After participants completed the IRX-2 regimen and the tumor resection was performed, tumor pathology was evaluated from tissue specimens obtained at tumor resection. Formalin-fixed, paraffin-embedded blocks, or unstained slides from the primary tumor were submitted to an independent pathology laboratory for hematoxylin and eosin staining, and evaluation of lymphocyte infiltration (LI). Participants were grouped into a "low LI" and "high LI" group based on the change in lymphocyte infiltration from the pretreatment tumor biopsy to the post-treatment tumor surgical resection. 5-year overall survival probabilities were then estimated (Kaplan-Meier) between the "low LI" and "high LI" groups

Sponsors and collaborators

Lead sponsor

Brooklyn ImmunoTherapeutics, LLC

Industry

Registry information

Official study title

A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck

Important dates

Study start
2005
Primary completion
2010
Study completion
2012
First posted
Sep 21, 2005
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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