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IAP Antagonist

Birinapant + IMRRT for Head and Neck Cancer

Phase 1
Waitlist Available
Led By Vassiliki Saloura
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically or cytologically confirmed locally recurrent HNSCC, including nasopharyngeal or sinonasal cancer for whom re-irradiation for local control is considered standard of care
Patients with human papillomavirus (HPV)-negative or HPV-positive head and neck cancer are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post-treatment
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of birinapant given with IMRRT for head and neck squamous cell carcinoma that has come back. Birinapant may stop the growth of tumor cells by blocking 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.

Who is the study for?
This trial is for adults with locally recurrent head and neck squamous cell carcinoma, including nasopharyngeal or sinonasal cancer. Candidates must have previously undergone platinum- or cetuximab-based therapy, be at least 4 weeks post chemotherapy/immunotherapy, and at least 6 months post radiotherapy. They should not have had more than two lines of systemic therapy and must not be HIV positive on antiretroviral therapy.Check my eligibility
What is being tested?
The trial tests birinapant in combination with intensity-modulated re-irradiation therapy (IMRRT) to treat recurring head and neck cancer. Birinapant aims to block proteins that tumor cells need to survive while IMRRT targets the tumor with precision to minimize damage to healthy tissue.See study design
What are the potential side effects?
Potential side effects include typical reactions related to immune system suppression such as increased risk of infections, possible allergic reactions similar to other compounds like birinapant, issues from radiation exposure like skin irritation or fatigue, and general drug-related side effects which will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs) and other toxicities
Maximum tolerated dose (MTD)
Secondary outcome measures
BIRC2/3 copy gain in tumor tissue or in blood
Change in MLKL levels
Change in caspase 3 levels
+6 more

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741
30%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Wound dehiscence
10%
Vascular access complication
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (IMRRT, birinapant)Experimental Treatment2 Interventions
Beginning on day 1, patients undergo IMRRT 5 days a week (Monday-Friday). Patients also receive birinapant IV over 30 minutes on days 2 and 9 of each cycle. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Birinapant
2013
Completed Phase 2
~230
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,140 Total Patients Enrolled
Vassiliki SalouraPrincipal InvestigatorNational Cancer Institute LAO

Media Library

Birinapant (IAP Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03803774 — Phase 1
Nasopharyngeal Cancer Research Study Groups: Treatment (IMRRT, birinapant)
Nasopharyngeal Cancer Clinical Trial 2023: Birinapant Highlights & Side Effects. Trial Name: NCT03803774 — Phase 1
Birinapant (IAP Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03803774 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What key goals is this research trying to achieve?

"This trial, which will be tracked for up to 42 days, seeks to measure the occurrence of dose-limiting toxicities and other adverse reactions. Secondary goals are observing change in caspase 3 levels (i.e., increase in apoptosis/necroptosis marker), overall survival estimates at maximum tolerated dose level with 95% two-sided confidence interval, and FADD copy gain within tumor tissue or blood as an exploratory analysis into its association with response rate."

Answered by AI

How many participants can join this medical trial?

"Affirmative. Clinicaltrials.gov's information indicates that this medical investigation is still looking for participants, originally posted on July 1st 2019 and most recently updated October 6th 2022. This trial requires the recruitment of 34 subjects across 21 distinct sites."

Answered by AI

Is this research actively seeking volunteers?

"Correct. Data hosted on clinicaltrials.gov points to this medical study as actively seeking participants - it was initially posted on July 1st 2019 and last modified October 6th 2022. 34 people across 21 different centres are required for the trial's completion."

Answered by AI

Has the FDA sanctioned Intensity-Modulated Radiation Therapy?

"The safety of Intensity-Modulated Radiation Therapy was judged to be a 1, considering that this is merely a Phase 1 medical trial with minimal data regarding its efficacy and security."

Answered by AI

How many venues is this experiment taking place in?

"The full list of trial sites recruiting patients includes the University of Kansas Cancer Center at North Kansas City Hospital in North Kansas City, UM Sylvester Comprehensive Cancer Center at Deerfield Beach in Deerfield Beach, and HaysMed University of Kansas Health System in Hays. Additionally, there are 18 other medical centres participating as well."

Answered by AI

Are other investigators looking into the potential of Intensity-Modulated Radiation Therapy?

"Currently, two ongoing studies are exploring the potential of Intensity-Modulated Radiation Therapy. Neither is in Phase 3 yet. As for geographical data, 43 clinical trial sites across America are looking into this form of therapy; most notably within Sarasota, Florida."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma
2019. "Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03803774.
~2 spots leftby Apr 2025
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