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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00210470
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : February 8, 2012
Last Update Posted : December 11, 2020
Information provided by (Responsible Party):
Brooklyn ImmunoTherapeutics, LLC

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: IRX-2 Drug: Cyclophosphamide Drug: Indomethacin Drug: Zinc Drug: Omeprazole Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label Single Arm Phase 2a trial of Safety of IRX-2 in Patients with Operable Head and Neck Cancer
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official 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
Study Start Date : July 2005
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: IRX-2 Regimen
The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin, zinc supplementation, and omeprazole.
Biological: IRX-2
IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.

Drug: Cyclophosphamide
Single i.v. injection of low-dose (300 mg/m2) on Day 1
Other Names:
  • Cytoxan
  • cyclophosphane

Drug: Indomethacin
21 days of oral indomethacin, 25 mg. 3 times daily
Other Names:
  • Indocin
  • Indocid

Drug: Zinc
21 days of zinc gluconate (65 mg) as part of an oral multivitamin
Other Name: zinc gluconate

Drug: Omeprazole
21 days of 20 mg. orally
Other Name: Prilosec

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210470

Sponsors and Collaborators
Brooklyn ImmunoTherapeutics, LLC
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Principal Investigator: Jeffrey S. Moyer, MD University of Michigan Hospitals
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Brooklyn ImmunoTherapeutics, LLC
ClinicalTrials.gov Identifier: NCT00210470    
Other Study ID Numbers: IRX-2 2005-A
First Posted: September 21, 2005    Key Record Dates
Results First Posted: February 8, 2012
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brooklyn ImmunoTherapeutics, LLC:
Head and Neck Cancer
Mouth Cancer
Throat Cancer
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Trace Elements
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic