A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head...
Head and Neck NeoplasmsHead and Neck Cancer1 moreThe study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.
Study of the CD40 Agonistic Monoclonal Antibody APX005M
CancerNSCLC4 moreThis study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M in adults with solid tumors. Study is intended to establish the maximum tolerated dose and the overall safety and tolerability of APX005M in 3 different administration schedules.
In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol®
MelanomaHead and Neck Cancer2 moreThe purpose of this study is to evaluate the safety of sequential intratumoral (IT) plus intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol®) for treatment of study subjects with accessible solid tumors, with or without checkpoint blockers. Enrolled study subjects will receive Poly-ICLC (Hiltonol®) treatment alone or in combination with anti-PD-1 (Nivolumab, Pembrolizumab or Cemiplimab) or anti-PD-L1 (Atezolizumab or Durvalumab) over 6 months as defined in study treatment described below. MRI or CT imaging will be done per SOC at screening, 3 and 6-month time points.
Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck...
Head and Neck Basaloid CarcinomaRecurrent Head and Neck Squamous Cell Carcinoma22 moreThis randomized phase II trial studies how well ficlatuzumab with or without cetuximab works in treating patients with head and neck squamous cell carcinoma that has come back or spread to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and reproduce, and helps the immune system recognize and fight head and neck squamous cell carcinoma.
Pre- and Postoperative Nutrition in Head and Neck Cancer Patients
Head and Neck CancerThe purpose of the project is to investigate the effect of wound healing of a combined pre- and postoperative oral supplement, consisting of zinc, vitamin C, arginine and multivitamin, as a supplement for adequate nutrition in patients operated for head and neck cancer.
Manual Therapy and Use of the Dynasplint for Trismus in Patients With Head and Neck Cancer
NeoplasmsHead and Neck1 moreThe objectives of this pilot study are to determine the effectiveness of a manual therapy (MT) protocol plus the use of a dynamic jaw opening device on the maximal interincisor distance; on trismus symptoms; on pain-disability outcomes and on the quality of life, anxiety, and depression in subjects with trismus. The proposed pilot study will comprise a single subject design with multiple baseline measures and during treatment phases to determine the effectiveness of the treatment protocol. A minimum sample of 10 subjects will be recruited. The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will receive a MT protocol plus exercises and the use of the DTS device for 8 weeks. The first two weeks of treatment will involve only MT and opening exercises.After this initial 2 weeks, the DTS will be introduced. The participants will receive a session of 30-45 minutes of MT three/two times per week, for 8 weeks. All participants will be instructed how to use the Dynasplint® Trismus System at home. Analyses: Visual analyses will be performed on participant before, during, and after the intervention. The 2-standard deviation band method will be used to analyze the behavior of each participant on the outcome of interest before, during, and after the treatment. The minimally important difference levels in order to determine clinical relevance will be done. Two effect size indexes will be used: the percentage of non-overlapping data, and the percentage of improvement rate difference.
Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV)...
Head and Neck CancerHuman Papilloma VirusThis is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1 (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80 (CD80). An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled and assessed for safety before additional participants are enrolled. The initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab.
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous...
Ovarian CancerNon Small Cell Lung Cancer5 moreThe purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors...
Head and Neck CancerPrecancerous ConditionRATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.
Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis...
Oral MucositisThe purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score). A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.