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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03803774
The ClinicalTrials.gov registry entry for NCT03803774 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, 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 listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.