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IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity (INSPIRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by IRX Therapeutics
Sponsor:
Information provided by (Responsible Party):
IRX Therapeutics
ClinicalTrials.gov Identifier:
NCT02609386
First received: September 10, 2015
Last updated: February 17, 2017
Last verified: February 2017
History of Changes
  Purpose
The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to stimulate an immune response against the cancer.

Condition Intervention Phase
Squamous Cell Carcinoma of the Oral Cavity
 Biological: IRX-2
Drug: Cyclophosphamide
Drug: Indomethacin
Dietary Supplement: Zinc-containing multivitamin
Drug: Omeprazole
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

Further study details as provided by IRX Therapeutics:

Primary Outcome Measures:
  • Change in Event-Free Survival from baseline [ Time Frame: At each study visit after surgery: at 3,6,9,12,15,18, 21,24,30,36,42,48 months ]
    To determine if the event-free survival (EFS) of subjects treated with Regimen 1 is longer than for subjects treated with Regimen 2


Secondary Outcome Measures:
  • Change in Overall Survival from baseline [ Time Frame: At each study visit after surgery: at 3,6,9,12,15,18,21,24,30,36,42,48 months ]
    To determine if OS of subjects treated with Regimen 1 is longer than for subjects treated with Regimen 2

  • Change in safety from baseline in each Regimen using a pre-approved questionnaire (case report form) [ Time Frame: At each study visit after surgery: at 3,6,9,12,15,18,21,24,30,36,42,48 months ]
    Medical professional will assess according to pre-specified list for patient response, lab results, adverse events, etc. at pre-specified intervals. Pain to be assessed using NCI Criteria grade from the following: None, Mild, Moderate or Severe

  • Change in tumor size from baseline to surgery [ Time Frame: Measured at time of pre-screening and at time of surgery (approx. 6-7 weeks) ]
    CT/MRI scan measurement, in cm.

  • Change in lymphocyte infiltrates in tumor comparing pre-treatment biopsy and surgical specimens [ Time Frame: Measured at time of pre-screening and at time of surgery (approx. 6-7 weeks) ]
    Computerized counting of lymphocyte infiltration
Estimated Enrollment: 200
Study Start Date: December 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1
IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy.
 Biological: IRX-2
Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.
Other Name: Immunotherapy
Drug: Cyclophosphamide
Method of Administration: Cyclophosphamide is administered once by IV
Other Names:
  • Cytophosphane
  • Cytoxan
Drug: Indomethacin
Method of Administration: Indomethacin is administered orally for 21 days.
Other Names:
  • NSAID
  • Indocin
Dietary Supplement: Zinc-containing multivitamin
Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
Other Names:
  • Zinc
  • Multi-vitamin
Drug: Omeprazole
Method of Administration: Omeprazole is administered orally for 21 days
Other Names:
  • Proton pump inhibitor
  • Prilosec
Active Comparator: Regimen 2
Regimen 1 but without IRX-2
 Drug: Cyclophosphamide
Method of Administration: Cyclophosphamide is administered once by IV
Other Names:
  • Cytophosphane
  • Cytoxan
Drug: Indomethacin
Method of Administration: Indomethacin is administered orally for 21 days.
Other Names:
  • NSAID
  • Indocin
Dietary Supplement: Zinc-containing multivitamin
Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
Other Names:
  • Zinc
  • Multi-vitamin
Drug: Omeprazole
Method of Administration: Omeprazole is administered orally for 21 days
Other Names:
  • Proton pump inhibitor
  • Prilosec

Detailed Description:

This study will assess the activity and safety of the IRX Regimen in participants with newly diagnosed, untreated, surgically resectable squamous cell cancer of the oral cavity. Participants will be randomly assigned to receive either Regimen 1: IRX-2 + cyclophosphamide + indomethacin + zinc + omeprazole, or Regimen 2: cyclophosphamide + indomethacin + zinc + omeprazole.

The primary study hypothesis is that the Regimen 1 with IRX-2 prolongs event-free survival and overall survival when compared to Regimen 2 without IRX-2.

Subjects will be randomized to either Regimen 1 or Regimen 2 on a 2:1 basis and treated prior to surgery.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically confirmed (histology or cytology) Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip)
  2. Disease surgically resectable with curative intent
  3. Hematological function: hemoglobin >9 g/dL; lymphocyte count >500 x 109/mL; neutrophil count >1500 x 109/mL; platelet count >100,000 x 109/mL
  4. Hepatic function: serum albumin >3.0 g/dL; aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <3x the upper limits of normal (ULN); alkaline phosphatase <2x the ULN
  5. Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN
  6. Calculated creatinine clearance > 50 mL/minute (Appendix 3)
  7. At least 18 years of age
  8. Willing and able to give informed consent and adhere to protocol therapy
  9. Karnofsky performance status (KPS) >=70%
  10. Able and willing to use a medically acceptable form of pregnancy prevention
  11. Negative urine/serum pregnancy test, if applicable

Exclusion Criteria:

  1. Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer.
  2. Any medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately
  3. Clinical status of either subject or tumor such that administration of 21 day neoadjuvant IRX-2 Regimen 1 or 2 before surgery would be medically inappropriate
  4. Tumor of the oropharynx
  5. Other clinical issues that would make participation in this clinical trial inappropriate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02609386

Contacts
Contact: IRX INSPIRE INSPIRE@IRXTherapeutics.com

Locations
United States, Arizona
Banner University Medical Center Recruiting
Tucson, Arizona, United States, 85742
Contact: Crystal Placencia       CPlacencia@uacc.arizona.edu   
Principal Investigator: Audrey Erman, MD         
United States, Arkansas
University of Arkansas For Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kathryn Allen       KGAllen@uams.edu   
Principal Investigator: Emre Vural, MD         
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Gina Tse       tse_g@med.usc.edu   
Principal Investigator: Jorge Nieva, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Manjit Gill    650-721-6399    manjit.gill@stanford.edu   
Principal Investigator: Michael Kaplan, MD         
United States, District of Columbia
Washington DC VA Medical Center Withdrawn
Washington, District of Columbia, United States, 20422
United States, Georgia
Emory Univeristy - Winship Cancer Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Nikki Hirsh       nikkihirsh@emory.edu   
Principal Investigator: Mihir Patel, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Joy Kimbrough       jidiaz0@uky.edu   
Principal Investigator: Joseph Valentino, MD         
United States, Massachusetts
Lahey Hospital & Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Bharat Yarlagadda, MD    781-744-8450      
Principal Investigator: Bharat Yarlagadda, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Terri Jobkar       tjobkar@med.umich.edudu   
Principal Investigator: Jeffrey Moyer, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Terry Burke       tburke@unmc.edu   
Principal Investigator: Aru Panwar, MD         
United States, New York
Monter Cancer Center - North Shore LIJ Recruiting
New Hyde Park, New York, United States, 11040
Contact: Vimla Singh       vsingh11@northwell.edu   
Sub-Investigator: Dev Kamdar, MD         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Christina Persaud       Cpersaud9@northwell.edu   
Principal Investigator: Dennis Kraus, MD         
United States, Oklahoma
Univeristy of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Pamela Wilda       Pamela-Wilda@ouhsc.edu   
Principal Investigator: Greg Krempl, MD         
United States, Oregon
Providence Cancer Center Recruiting
Portland, Oregon, United States, 97209
Contact: Brenda Fisher       brenda.fisher@providence.org   
Principal Investigator: Bryan Bell, MD DDS FACS         
United States, Pennsylvania
Hospital of The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Samantha Jaffe       samantha.jaffe@uphs.upenn.edu   
Principal Investigator: Jason Newman, MD         
Sponsors and Collaborators
IRX Therapeutics
Investigators
Principal Investigator: Gregory T Wolf, MD, FACS University of Michigan Hospitals
  More Information

Additional Information:
INSPIRE Trial website  This link exits the ClinicalTrials.gov site
Sponsor's website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: IRX Therapeutics
ClinicalTrials.gov Identifier: NCT02609386     History of Changes
Other Study ID Numbers: IRX-2 2015-A
Study First Received: September 10, 2015
Last Updated: February 17, 2017

Keywords provided by IRX Therapeutics:
Head and Neck Neoplasms
Immunotherapy
Cancer
Oral Cavity

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Cyclophosphamide
Indomethacin
Omeprazole
Proton Pump Inhibitors
Zinc
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Gout Suppressants

ClinicalTrials.gov processed this record on May 25, 2017