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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.
Verified February 2017 by IRX Therapeutics
Sponsor:
IRX Therapeutics
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
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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: None (Open Label) 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:
Drug: Indomethacin
Method of Administration: Indomethacin is administered orally for 21 days.
Other Names:
Dietary Supplement: Zinc-containing multivitamin
Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
Other Names:
Drug: Omeprazole
Method of Administration: Omeprazole is administered orally for 21 days
Other Names:
|
|
Active Comparator: Regimen 2
Regimen 1 but without IRX-2
|
Drug: Cyclophosphamide
Method of Administration: Cyclophosphamide is administered once by IV
Other Names:
Drug: Indomethacin
Method of Administration: Indomethacin is administered orally for 21 days.
Other Names:
Dietary Supplement: Zinc-containing multivitamin
Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
Other Names:
Drug: Omeprazole
Method of Administration: Omeprazole is administered orally for 21 days
Other Names:
|
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:
- Pathologically confirmed (histology or cytology) Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip)
- Disease surgically resectable with curative intent
- 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
- 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
- Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN
- Calculated creatinine clearance > 50 mL/minute (Appendix 3)
- At least 18 years of age
- Willing and able to give informed consent and adhere to protocol therapy
- Karnofsky performance status (KPS) >=70%
- Able and willing to use a medically acceptable form of pregnancy prevention
- Negative urine/serum pregnancy test, if applicable
Exclusion Criteria:
- Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer.
- 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
- 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
- Tumor of the oropharynx
- 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
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:
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 Zinc Omeprazole Proton Pump Inhibitors 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 Micronutrients Growth Substances Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on September 21, 2017