Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03803774 · ClinicalTrials.gov registry record · Phase 1
Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma
A Phase 1 study of Locally Recurrent Head and Neck Squamous Cell Carcinoma and Sinonasal Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 20
- Study locations
NCT03803774: Active Phase 1 study of Locally Recurrent Head and Neck Squamous Cell Carcinoma and Sinonasal Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03803774 is a Phase 1 study of Locally Recurrent Head and Neck Squamous Cell Carcinoma and Sinonasal Squamous Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 100-participant average among 4 other Locally Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03803774, a Phase 1 study of Locally Recurrent Head and Neck Squamous Cell Carcinoma and Sinonasal Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. A DLT is defined as any of the following adverse events possibly attributed to the combination of birinapant and radiotherapy that occur within 42 days after treatment. Any grade 5 toxicities. Any grade ≥ 4 hematologic toxicity, except lymphopenia. Any grade ≥ 3 non-hematologic toxicity except for nausea or vomiting managed with supportive care over 2 weeks.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Birinapant
Study Locations (20)
Kansas
- University of Kansas Clinical Research Center - Fairway
- HaysMed - Hays
- University of Kansas Cancer Center - Kansas City
- Lawrence Memorial Hospital - Lawrence
- The University of Kansas Cancer Center - Olathe - Olathe
- University of Kansas Cancer Center-Overland Park - Overland Park
- Mercy Hospital Pittsburg - Pittsburg
- Salina Regional Health Center - Salina
- University of Kansas Health System Saint Francis Campus - Topeka
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
- Moffitt Cancer Center-International Plaza - Tampa
- Moffitt Cancer Center - McKinley Campus - Tampa
- Moffitt Cancer Center - Tampa
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2026-07-09 |
| Phase | Phase 1 |
What the registry record for NCT03803774 still lists
NCT03803774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 100-participant average among 4 other Locally Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Locally Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03803774 names 20 study sites across 4 states, led by Kansas, Florida, California.
Frequently Asked Questions
What is clinical trial NCT03803774 about?
NCT03803774 is a clinical study titled "Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma". 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 re...
What is the current status of trial NCT03803774?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-09-25. Estimated completion is 2026-07-09.
What conditions does trial NCT03803774 study?
This clinical trial studies the following conditions: Locally Recurrent Head and Neck Squamous Cell Carcinoma, Sinonasal Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT03803774?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Intensity-Modulated Radiation Therapy (RADIATION), Birinapant (DRUG).
Who is sponsoring clinical trial NCT03803774?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03803774 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Locally Recurrent Head and Neck Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma
RECRUITING · Phase 1
-
Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
RECRUITING · Phase 1
-
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
RECRUITING · Phase 2
-
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03125655 · 13 participants
Regulation of Inflammatory Genes in Psoriasis
- NCT03774446 · 13 participants · Phase 2
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
- NCT03830151 · 13 participants · Phase 1
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
- NCT04573231 · 13 participants · Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI