IAP Antagonist

Intensity-Modulated Radiation Therapy for Nasopharyngeal Cancer

Q: What key goals is this research trying to achieve?

<p>This trial, which will be t<a href="https://www.withpower.com/clinical-trials/ra">ra</a>cked 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.</p>

Q: Has the FDA sanctioned Intensity-Modulated Radiation Therapy?

<p>The safety of Intensity-Modulated Radiation The<a href="https://www.withpower.com/clinical-trials/ra">ra</a>py was judged to be a 1, considering that this is merely a Phase 1 medical trial with minimal data regarding its efficacy and security.</p>

Ohio State University Comprehensive Cancer Center, Columbus, OH

Targeting 3 different conditionsIntensity-Modulated Radiation Therapy +1 morePhase 1RecruitingLed by Vassiliki SalouraResearch 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 must have received curative-intent platinum- and/or cetuximab-based chemoradiotherapy or radiotherapy alone

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 24 months post-treatment

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Head and Neck Squamous Cell Carcinoma
Nasopharyngeal Cancer
Sinonasal Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

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

Select...

You have not received any immune therapies before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post-treatment

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%

Nausea

20%

Thrombosis

20%

Hemoglobin decreased

20%

Lymphopenia

20%

Alanine aminotransferase increased

20%

Hyperglycemia

20%

Hyponatremia

20%

Seizure

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%

Alopecia

10%

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Pre-Randomization TMZ+RT

Randomized Arm 1: TMZ+RT + Placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Not yet FDA approved

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~1800

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,412 Previous Clinical Trials

41,239,032 Total Patients Enrolled

Vassiliki SalouraPrincipal Investigator

National 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.

All > Squamous Cell Carcinoma