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Clinical Trials: Cancer - Head and Neck, Including Mouth
IRB No. 11-191-1 (Dr. Rajesh Lalla, PI): Quality Assessment of Pre-Radiation Dental Management in Head and Neck Cancer Patients
Oral Medicine Quality Assurance Study
IRB No. 14-179-1 (Dr. Rajesh Lalla, PI): Oral Microbiome in Head and Neck Cancer Patients
This research study is about the community of germs that live in the mouth (the oral microbiome) and its relationship to oral complications of radiation therapy such as dryness, mouth sores, tooth loss, cavities, gum disease or poor healing of bone. The purpose of this study is to look at changes in the oral microbiome from before radiation therapy until 18 months after radiation therapy to see if certain characteristics of the oral microbiome relate to mouth problems that may occur after radiation therapy. An optional sub-study is about future genetic testing of saliva samples to look for genes that may affect the risk of oral complications of radiation therapy..
IRB No. 16-007-1 (Dr. Upendra Hegde, PI): A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Head and neck cancer describes a range of tumors that arise in the head and neck region, which includes the oral cavity, pharynx, larynx, nasal cavity, paranasal sinuses, thyroid, and salivary glands. The worldwide incidence of head and neck cancer exceeds half a million cases annually, ranking it as the fifth most common cancer worldwide, and accounts for 5% of all malignancies. A large number of patients with head and neck cancer initially present with locally advanced, stage III/IV disease that is initially treated with combinations of chemotherapy, radiation and/or surgery. This initial treatment is generally designated as "definitive" therapy, which typically combines chemoradiation and surgery and can result in disease control rates ranging between 33 and 86% of patients. Patients who progress after initial definitive therapy require subsequent treatment for recurrent (R) disease. Patients who initially present with metastatic (M) disease generally receive the same therapy as those with recurrent disease after definitive treatment. In this trial, subjects with oropharynx cancer will be stratified by HPV status (positive or negative). The favorable prognostic significance of HPV-positive head and neck cancers in the oropharynx has been increasingly established. Preliminary data of single agent pembrolizumab in head and neck cancer patients in KEYNOTE-012 demonstrate efficacy in both HPV-positive and HPV-negative patients. Investigator site assessment of HPV using immunohistochemistry (IHC) staining for the p16 protein will be used for the subjects with oropharyngeal cancer prior to randomization. Study design This is a randomized, active-controlled, multi-site, open-label trial of pembrolizumab, or pembrolizumab plus platinum plus 5-FU chemotherapies versus platinum plus 5-FU plus cetuximab in subjects with advanced head and neck cancer. Study population and sample size Subjects with recurrent or metastatic Head and Neck Squamous Cell Carcinoma. Approximately 750 subjects will be enrolled. Major Study Interventions (1) Pembrolizumab (MK-3475) 200 mg every 3 weeks; or (2) Pembrolizumab (MK-3475) 200 mg every 3 weeks + Platinum + 5- Fluorouracil (5-FU); or (3) Cetuximab 400 mg/m2 initial dose followed by 250 mg/m2 (weekly) + Platinum + 5FU (Platinum is either Cisplatin 100 mg/m2 Q3W or Carboplatin AUC 5 Q3W; 5FU is 1000 mg/m2 continuous from Day 1 to Day 4 Q3W) Main Outcome Measures/Analyses Primary Objectives (1) Objective: To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by central radiologists' review in a subgroup of first line recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects with strongly positive PD-L1 expression, treated with Pembrolizumab monotherapy versus standard treatment cetuximab with chemotherapy. (2) Objective: To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by central radiologists' review in subjects with first line R/M HNSCC treated with pembrolizumab monotherapy or a combination of Pembrolizumab with chemotherapy versus standard treatment cetuximab with chemotherapy.
IRB No. 14-041HO-1 (Dr. Rajesh Lalla, PI): Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)
The ORARAD study is a prospective cohort study to document dental and other oral outcomes in patients who receive radiation therapy as part of treatment for a head and neck cancer. Seven hundred and fifty-six participants will be enrolled nationally over a three year period. Of these, 135 will be enrolled at UCHC. All participants will be seen for the study before starting radiation therapy then at six-month intervals for up to two years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss after radiation therapy. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.
Background: PF-04518600 and PF-05082566 are antibodies (a type of protein) which have been shown to stimulate the immune system. Research has shown that an immune response like this can work against tumor cells to slow tumor growth by causing tumor cells to die. PF-04518600 alone and in combination with PF-05082566 are being investigated as possible treatments for patients with advanced liver, skin (melanoma), kidney, head and neck, stomach, cervical, gastric, bladder or lung cancer. Rationale for this study: The ability to escape immune recognition is a hallmark of cancer progression. By manipulating the immune system and restoring immune surveillance, immunotherapy offers the opportunity to not only eradicate or stop tumor growth, but also the opportunity to decrease the rate of recurrence.1 One strategy for increasing tumor immunity would be to activate and expand tumor-associated antigen T cells. It has long been recognized that T cell activation is not mediated by antigen stimulation alone. Indeed, tumor antigens may induce T-cell anergy, rendering T cells unable to proliferate in response to antigen, and hypo-responsive to further antigen encounter. Instead, co-stimulatory receptors are required to complete the process of T cell activation and expansion. Thus, co-stimulatory receptors may have the potential to prevent tumor-induced immune tolerance. PF-04518600 is a fully human Immunoglobulin G2 (IgG2) agonistic monoclonal antibody that is highly selective for human OX40 (CD134). PF-04518600’s agonistic potential was revealed in a 293 luciferase reporter assay, whereby induced OX40 mediated NFkB activation, and luciferase activity increased dose proportionally to increasing concentrations of PF-04518600. Selectivity studies using a biacore assay also revealed PF-04518600 to be highly selective for OX40, with no cross activity with other members of the TNFR super-family, including CD40 receptor, 4-1BB receptor (CD137) and glucocorticoid-induced TNFR family related gene (GITR). Study Design: This is a Phase 1, open label unblinded manner, multi-center, multiple dose, dose escalation, safety,pharmacokinetic, and pharmacodynamic study of PF-04518600 monotherapy (Part A) and PF-04518600 plus PF-05082566 combination therapy (Part B). Both Part A and Part B will be further divided into a dose escalation phase, and a dose expansion phase. Study Population and Sample Size: Adults (men and women) age 18 years and over. Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, clear cell RCC urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix. A maximum of approximately 190 patients are expected to be enrolled into the study. Major Study Interventions: For monotherapy, patients will be dosed at 0.01 mg/kg PF-04518600 in the first cohort. For combination therapy, patients will be dosed at 0.1 mg/kg PF-04518600 and 20 mg PF-05082566 in the first dose combination level. Main Outcome measures /Analyses: To assess safety, and tolerability at increasing dose levels of PF-04518600 in patients with selected advanced or metastatic solid tumors in order to establish the MTD. Primary Objectives: -To establish the RP2D of PF-04518600 in patients with selected advanced or metastatic solid tumors. To further characterize the safety and tolerability of PF-04518600 in patients with selected advanced or metastatic solid tumors. Secondary Objectives: -To assess preliminary anti-tumor clinical activity of PF-04518600 in patients with selected advanced or metastatic solid tumors solid tumors. To characterize the single dose and multiple dose PK of PF-04518600 following IV administration. -To characterize the degree of TE by PF-04518600 at multiple doses