Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT03803774. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Birinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial studies the side effects and best dose of birinapant when given together with intensity modulated re-irradiation therapy (IMRRT) in treating patients with head and neck squamous cell carcinoma that has come back at or near the same place as the original (primary) tumor (locally recurrent). Birinapant may stop the growth of tumor cells by blocking inhibitor of apoptosis (IAP), a protein needed for tumor cell survival. IMRRT uses thin beams of radiation of different intensities that are aimed at the tumor from many angles. This type of re-irradiation therapy reduces the damage to healthy tissue near the tumor. Giving birinapant with IMRRT may lower the chance of head and neck squamous cell carcinoma growing or spreading.
Study identification
- NCT ID
- NCT03803774
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 13 participants
Conditions and interventions
Conditions
Interventions
- Biopsy Procedure Procedure
- Birinapant Drug
- Computed Tomography Procedure
- Intensity-Modulated Radiation Therapy Radiation
- Magnetic Resonance Imaging Procedure
- Positron Emission Tomography Procedure
Procedure · Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 25, 2019 (Actual)
- Primary completion
- Nov 15, 2023 (Actual)
- Completion
- Jul 9, 2027 (Estimated)
- Last update posted
- Aug 3, 2026
2019 – 2027
United States locations
- U.S. sites
- 33
- U.S. states
- 11
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| Moffitt Cancer Center-International Plaza | Tampa | Florida | 33607 | — |
| Moffitt Cancer Center - McKinley Campus | Tampa | Florida | 33612 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | — |
| HaysMed | Hays | Kansas | 67601 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| The University of Kansas Cancer Center - Olathe | Olathe | Kansas | 66061 | — |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | — |
| Mercy Hospital Pittsburg | Pittsburg | Kansas | 66762 | — |
| Salina Regional Health Center | Salina | Kansas | 67401 | — |
| University of Kansas Health System Saint Francis Campus | Topeka | Kansas | 66606 | — |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| NCI - Center for Cancer Research | Bethesda | Maryland | 20892 | — |
| University Health Truman Medical Center | Kansas City | Missouri | 64108 | — |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | — |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | — |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Wake Forest Baptist Health - Wilkes Medical Center | Wilkesboro | North Carolina | 28659 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03803774, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03803774 live on ClinicalTrials.gov.