Active clinical trials for "Head and Neck Neoplasms"

This is a Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. VCN-01 is a genetically modified oncolytic adenovirus characterized by the presence of four independent genetic modifications on the backbone of the wild-type HAd5 adenovirus genome, encoding human PH20, that confer tumor selectivity and anti-tumor activity. Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1. The proposed mechanism of action (MOA) for durvalumab is interference in the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, including those that may result in tumor elimination.

This is a Phase 1 study of the use of an investigational drug that selectively delivers radiation to malignant tumor cells, CLR 131, in combination with external beam radiation therapy (EBRT) in subjects with locoregionally recurrent head and neck cancer. The trial will enroll up to 12 participants who are amenable to retreatment with radiation therapy. Participants who also have distant metastatic disease may be enrolled on this clinical trial, but they must have evaluable disease that will be clinically treated with radiation therapy, as per standard of care. All participants will receive a dosimetry test dose of CLR 131 to establish drug uptake by the tumor and enable Monte Carlo dose estimation based on CLR 131 SPECT/CT imaging evaluation. Participants showing uptake will receive a cumulative tumor dose of 60-70 Gy using personalized dose calculation (via Monte Carlo methods) of CLR 131 combined with external beam radiation.

The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.

This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer.

The incidence of head and neck cancer is increasing in the Western World, including Denmark. Cancer of the head and neck and its treatment often have a detrimental and lifelong impact on the quality of life of the patients. Radiotherapy is a key component for approximately 80% of all patients with head and neck cancer and despite the enormous improvement in ionizing radiotherapy, the radiation still leads to significant ionizing of healthy tissue, including the radiation-sensitive salivary glands. Salivary glands suffer severe damage from radiation, and as these cells are the principal sites of fluid secretion one of the most prevalent side effect of irradiation for head and neck cancer is hyposalivation and dry mouth syndrome, xerostomia. Xerostomia leads to debilitating oral disorders and major implication for the overall quality of life, including social life and professional life. Currently, only symptomatic treatment is available to patients suffering from xerostomia, and therefore there is an immense, unmet need for new treatment strategies for hyposalivation and xerostomia. Stem cells have been identified as a potential treatment modality for a wide variety of disorders by their ability to differentiate into many functional cell types, and stem cells have been suggested as an approach to restoring the function of salivary glands after radiotherapy damage. The purpose of the study is to assess the efficacy and safety of the injection of stem cells from healthy donors on radiation-induced salivary gland hypofunction and xerostomia in previous head and neck cancer patients. The project can potentially help to develop a clinically relevant treatment option for the growing number of patients suffering from xerostomia after irradiation. The development of new therapies is especially meaningful since only sub-optimal, symptomatic treatments are currently available, and since the symptom of xerostomia immensely reduces quality of life.

Dysphagia affects 22% of those over the age of 50, which equates to 250 million people worldwide and 360,000 in Alberta. At high risk are survivors of head and neck cancer (70%). Difficulties with swallowing are not only life threatening and resource-intense, but also socially limiting. To regain swallowing function and avoid or reduce the consequences of dysphagia, patients require regular, intensive therapy over many months to strengthen swallowing muscles and improve swallow coordination. This therapy is often coupled with visual biofeedback that uses surface electromyography (sEMG). Despite evidence that swallowing exercises are effective when provided with an intensive regimen and when coupled with sEMG biofeedback, patients rarely receive it. The primary aim of this work is to determine whether the use of a mobile system equipped with sEMG biofeedback affects adherence to home-based swallowing exercises. The secondary aim of this work is to determine if the exercise program results in improved patient reported outcomes related to dysphagia and nutrition. Our tertiary aim is to determine if previous findings of adherence can be replicated. Sixty adults with oropharyngeal dysphagia secondary to OPSCC treatment will be enrolled in the study. This study will follow a cross over randomized design such that all participants will be provided with both types of treatment: using pen and paper (Treatment Arm A) and using the mobile health system (Treatment Arm B).

Part1: A mutilpe-center, open-label, Phase II clinical trial to evaluate the efficacy and the safety of HLX10 in combination with HLX07 in patients with advanced advanced head and neck tumors. Part2: A randomized, double-blind, multi-center, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 in combination with HLX07 and chemotherapy versus HLX10 in combination with placebo and chemotherapy in the first-line treatment of R/M HNSCC.

The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.

Chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma is palliative and usually platinum based, and the patients often present with poor physical condition. Consequently, many of them are not able to withstand a platinum-based chemotherapy. The addition of taxanes to the armamentarium of drugs improve the outcome in this group of patients. An alternative and better tolerated regimen for these patients is paclitaxel in combination with cetuximab, included the in guidelines of the Spanish Society of Medical Oncology. Recently, new treatments such as immune-checkpoint inhibitors have shown promising activity and good tolerability in patients with recurrent or metastatic head and neck squamous cell carcinoma and has been included in the recently published guidelines from the Society for Immunotherapy of Cancer. Nivolumab (anti-PD1) has been approved for patients progressing on or after platinum-based therapy, as it clearly impacts on overall survival. This randomized phase II study will evaluate the efficacy of nivolumab plus paclitaxel for first-line treatment of recurrent or metastatic HNSCC in the platinum ineligible and platinum refractory settings. Control arm will be paclitaxel in combination with cetuximab, treatment included in the guidelines of the Spanish Society of Medical Oncology.

The goal of this clinical trial is to evaluate the safety of applying BNCT with the dose optimization in patients with recurrent head and neck cancer. The main questions it aims to answer are: - Dose optimized BNCT are conducted safety in these patients. Participants will receive dose optimized BNCT regulated as 12, 15, 18 Gy-Eq of the mucosal dose.