Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Mouth Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Oral Cancer

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Analgesics

Reproductive Control Agents

Gastrointestinal Agents

Micronutrients

Cyclophosphamide

Indomethacin

Immunomodulating Agents

Omeprazole

Zinc

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Trace Elements

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Tocolytic Agents

Cyclooxygenase Inhibitors

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.

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

IRX-2

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

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

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

Jeffrey S. Moyer, MD

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).

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.

Open Label Single Arm Phase 2a trial of Safety of IRX-2 in Patients with Operable Head and Neck Cancer

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

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

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

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

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.

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

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).

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)

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.

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

Brooklyn ImmunoTherapeutics, LLC

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 and zinc supplementation.

IRX-2 Regimen

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Mexico

Region of Enrollment

Gregory T. Wolf

Adverse Event: Injection Site Pain

Adverse Event: Headache

Adverse Event: Nausea

Adverse Event: Constipation

Adverse Event: Dizziness

Adverse Event: Fatigue

Adverse Event: Pneumonia Aspiration

Adverse Event: Anaemia

Adverse Event: Injection Site Discomfort

Adverse Event: Myalgia

Adverse Event: Contusion

Adverse Event: Dry Mouth

Adverse Event: Vomiting

Additional AE Categories w lower frequency

Serious Adverse Events

A 2-week course of IRX-2, an initial low dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation

27 participants were entered into study and treated. All participants were included in the safety analysis.

Number of Participants With Adverse Events and Serious Adverse Events

-20% to < -10%

-10% to < 0%

0% to < 10%

10% to < 20%

20% to < 30%

>= 30%

A total of 23 subjects who received the IRX-2 regimen were evaluated for tumor response based on the RECIST criteria

Clinical and Histological Tumor Responses

Median Days in hospital

Median Days in intensive care unit

Median Days in step-down unit

Following surgery the median days spent in the hospital, intensive care unit and step down unit was determined for 26 subjects

Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;

Positive at both Baseline and at Day 21 (%)

Negative at both Baseline and Day 21 (%)

Positive at Baseline and Negative Day 21 (%)

Negative at Baseline and Positive at Day 21

Induration at Day 21

Skin response (erythema) was evaluated at Baseline and Day 21 on 26 subjects treated with IRX-2 Regimen

Immune Competence as Measured by Skin Test Reactivity

1-year disease free survival probability

2-year disease free survival probability

3-year disease free survival probability

Disease-free Survival

First Year (%)

Second Year (%)

Third Year (%)

Overall Survival

Number of patients with high lymphocyte infiltration (LI).

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

Participants with high lymphocyte infiltration after treatment with the IRX-2 regimen

High Lymphocyte Infiltration (LI)

Participants with low lymphocyte infiltration after treatment with the IRX-2 regimen

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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