Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Tongue Neoplasms

Laryngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Mouth Neoplasms

Mouth Diseases

Tongue Diseases

Oral Squamous Cell Carcinoma

Laryngeal Cancer

Hypopharyngeal Cancer

Oral Cancer

Patients undergo radiation therapy QD 5 days a week (Monday through Friday) for the first 18 days and then BID for 15 days in the absence of disease progression or unacceptable toxicity.

Proton Beam Radiation Therapy

Quality-of-Life Assessment

Questionnaire Administration

Clifton D Fuller

This phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. The change in dose radiation frequency and dose investigated in this study may help to better control the tumor and prevent it from coming back or growing. The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence (the tumor comes back after treatment).

PRIMARY OBJECTIVE:

I. To assess the safety \& feasibility of image guided mid-treatment hyper-fractioned dose-escalation with proton therapy and identify the maximum tolerable dose (MTD) for the treatment of locally advanced human papillomavirus (HPV) negative head and neck cancer.

OUTLINE:

Patients undergo radiation therapy once daily (QD) 5 days a week (Monday through Friday) for the first 18 days and then twice daily (BID) for 15 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 8 weeks, 3, 6, 9, and 12 months in the first year after radiation therapy, every 4 months in the second year after radiation therapy, and then every 9 months thereafter.

Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer

Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients [PIRATES]

Specifically, Common Terminology Criteria for Adverse Events (CTCAE) version 5 grade 4 mucositis, dermatitis or aspiration that does not resolve to a grade =\< 3 in 3 months, and CTCAE version 5 grade \>= 3 myelopathy, and/or osteonecrosis. Summary statistics, including mean, standard deviation and 95% confidence interval will be used to describe safety data. Toxicity will be tabulated and summarized by grade and type.

Specifically, CTCAE version 5 grade 3 mucositis, dermatitis, aspiration, dysphagia, hearing impaired, xerostomia, weight loss, trismus, hoarseness, oropharyngeal pain. Summary statistics, including mean, standard deviation and 95% confidence interval will be used to describe safety data. Toxicity will be tabulated and summarized by grade and type. Radiation induced side effect (RISE) rate will be summarized by frequency, standard deviation and 95% confidence interval.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity.

Tolinapant

Radiation Therapy

Nicole C Schmitt, MD

Nabil F Saba, MD

Allyson Anderson

This early-phase trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past (previously untreated), has spread to nearby tissue or lymph nodes (locally advanced) and cannot receive cisplatin (cisplatin-ineligible). Tolinapant may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tolinapant and radiation therapy may kill more tumor cells.

Primary Objective:

To evaluate the safety and tolerability of the recommended phase 2 dose (RP2D) of tolinapant when given in combination with radiation.

Secondary Objectives:

To assess preliminary efficacy of the combination of tolinapant and radiation in cisplatin ineligible patients with head and neck cancer as determined by locoregional control, two year progression-free survival (PFS), and two-year overall survival (OS).

Exploratory Objective:

To compare immune cell infiltrates following the first cycle of tolinapant + radiation, compared with baseline biopsy tissue and peripheral blood.

TERTIARY/EXPLORATORY OBJECTIVES:

I. To assess the effects of the combination of tolinapant + radiation on immune cells in blood and tumor.

II. To assess the association between immune responses and FADD expression in tumors.

OUTLINE:

Patients undergo standard of care radiation therapy for a total of 35 fractions over 6-7 weeks and receive tolinapant orally (PO) daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up 1, 3, 6, 12, and 24 months.

Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer

Early-Phase Open-label Study of Tolinapant and Radiation in Cisplatin-Ineligible Patients With Previously Untreated, Locally Advanced Head and Neck Cancer

Safety will be assessed on clinical examination and measurement of laboratory parameters. All safety assessments including adverse events, clinical laboratory evaluations, and vital signs will be summarized with descriptive statistics, where appropriate, and listed in the data listings using MedDRA terms.

Feasibility is defined as completion of treatment, which will be reported as a percentage, with a 95% exact confidence interval using the Clopper-Pearson method.

Astex Pharmaceuticals, Inc.

Emory University

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer	NCT04870840	Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Malignant Poste... Stage II Cutane... Stage II Hypoph... Stage II Laryng... Stage II Nasoph... Stage II Oropha... Stage III Cutan... Stage III Hypop... Stage III Laryn... Stage III Nasop... Stage III Oroph... Unresectable He... Unresectable Or...	Proton Beam Rad... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer	NCT04870840	Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Malignant Poste... Stage II Cutane... Stage II Hypoph... Stage II Laryng... Stage II Nasoph... Stage II Oropha... Stage III Cutan... Stage III Hypop... Stage III Laryn... Stage III Nasop... Stage III Oroph... Unresectable He... Unresectable Or...	Proton Beam Rad... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer	NCT04870840	Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Malignant Poste... Stage II Cutane... Stage II Hypoph... Stage II Laryng... Stage II Nasoph... Stage II Oropha... Stage III Cutan... Stage III Hypop... Stage III Laryn... Stage III Nasop... Stage III Oroph... Unresectable He... Unresectable Or...	Proton Beam Rad... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer	NCT05245682	Head and Neck C... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance...	Tolinapant Radiation Thera...	18 Years -	Emory University

Spots Global Cancer Trial Database for locally advanced nasopharyngeal squamous cell carcinoma