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

December 10, 2020 updated by: Brooklyn ImmunoTherapeutics, LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • zinc gluconate
Drug: Omeprazole
21 days of 20 mg. orally
Other Names:
  • Prilosec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment through 30 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery
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.
Following surgery and post-operative therapy (up to 39 days post surgery)
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.
At approx. 21 days, prior to surgery
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).
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
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)
Time from surgery to death or confirmed recurrent or progressive disease, assessed up to 3 years
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.
On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery
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
At time of surgery, after treatment with IRX-2 Regimen, assessed up to 5 years

Collaborators and Investigators

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

Sponsor

Brooklyn ImmunoTherapeutics, LLC

Investigators

  • Principal Investigator: Jeffrey S. Moyer, MD, University of Michigan Hospitals

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

July 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRX-2 2005-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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