Squamous Cell Carcinoma

Researchers are studying oral squamous cell carcinoma to evaluate the use of intraoral ultra-high frequency ultrasonography as a diagnostic tool. The goal is to improve visualization of oral soft tissue lesions beyond the mucosal surface, supporting clinical diagnosis with a minimally invasive, repeatable, and cost-effective imaging method. This study focuses on how this ultrasound technique may help assess tumor characteristics in the mouth. Participants diagnosed with oral squamous cell carcinoma and eligible for surgery will undergo an intraoral ultrasound scan using a 70 MHz frequency probe. This device is designed to measure tumor depth of invasion and thickness before surgery, providing detailed imaging of the oral soft tissues. The study involves only this experimental ultrasound procedure for patients meeting the criteria. During the study, participants will receive the ultrasound scan preoperatively to measure the depth of invasion of their tumor. Researchers will collect this measurement as the primary outcome to assess the ultrasound's diagnostic role. The study includes monitoring for safety and adherence, with participants followed until study completion. The total duration and follow-up specifics depend on each participant's surgical timeline and study protocols.

Researchers are evaluating an imaging test called zirconium Zr89 panitumumab combined with PET/CT scans to detect the spread of head and neck squamous cell carcinoma to other parts of the body. This phase I trial aims to assess how well 89Zr panitumumab identifies uncertain metastatic lesions compared to standard imaging methods like MRI, CT, and 18F-FDG PET/CT. The study focuses on the sensitivity and specificity of this investigational imaging agent in diagnosing metastatic disease. Participants will receive intravenous infusions of panitumumab and 89Zr panitumumab, followed by a PET/CT scan within 1 to 5 days after the infusion. They will also undergo standard care evaluations and treatments for their suspected metastatic lesions. The study compares 89Zr panitumumab PET/CT results to those from usual imaging techniques to determine its diagnostic value. During the study, participants will have blood tests to check hemoglobin, white blood cell count, platelet count, and kidney function. Researchers will monitor the imaging results to measure sensitivity and specificity over up to seven years. The study also tracks how often invasive procedures like biopsies are chosen versus observation. Participants will be followed and evaluated for safety and diagnostic accuracy throughout the study period.

Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 0/1 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 1/2a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts: a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

Researchers are evaluating whether giving 2 courses of cisplatin chemotherapy along with postoperative radiotherapy is as effective as 3 courses in treating patients with high-risk head and neck squamous cell carcinoma after surgery. This phase 3 randomized trial focuses on patients with advanced stages (III and IV) of this cancer type who have undergone radical surgery but have high-risk factors such as extracapsular invasion or positive surgical margins. The main goal is to compare the 3-year failure-free survival rates between the two treatment approaches. Participants will be assigned to one of two groups. One group receives intensity-modulated radiotherapy totaling more than 66 Gy, given once daily five days a week, combined with cisplatin chemotherapy at 100 mg/m2 through intravenous injection on days 1 and 22 (2 courses). The other group receives the same radiotherapy schedule plus 3 courses of cisplatin chemotherapy on days 1, 22, and 43. Both treatments are delivered under medical supervision to assess outcomes and side effects. During the study, participants will undergo regular assessments to evaluate failure-free survival, overall survival, distant metastasis-free survival, locoregional recurrence-free survival, and quality of life over a 3-year period. Safety and treatment tolerability will also be monitored. The trial includes close follow-up visits and evaluations to measure the effects of the different chemotherapy schedules combined with radiotherapy on cancer control and patient well-being.

Researchers are evaluating advanced radiation treatment methods called stereotactic body radiotherapy (SBRT) to see if they can safely deliver a stronger dose of radiation to tumors in patients with head and neck squamous cell carcinoma (HN SCC) who are not eligible for curative treatment. The study compares SBRT with traditional radiation methods to understand differences in local tumor control, symptom relief, side effects, and survival outcomes. Participants are randomly assigned to receive either traditional palliative radiation or SBRT, with radiation schedules determined by the study doctor. This Phase II trial aims to deliver radiation in fewer sessions with SBRT, potentially shortening treatment time compared to standard fractionated radiation. During the study, participants will undergo symptom assessments using the M. D. Anderson Symptom Inventory for head and neck cancer over about one year. Researchers will monitor pain response, symptom burden, tumor progression, and overall safety. The trial includes regular clinical evaluations and imaging to assess treatment effects, and participation may last up to approximately one year or more depending on individual follow-up.

Researchers are evaluating a new preoperative method using three-dimensional CT scans and virtual resection simulation to predict lung function after surgery in patients with non-small cell lung cancer (NSCLC) undergoing Video-Assisted Thoracoscopic Surgery (VATS). This study aims to improve accuracy over traditional methods by accounting for differences in lung ventilation caused by tumors or emphysema. It is a prospective, multi-center, longitudinal cohort study involving 60 patients split evenly between those having lobectomy and segmentectomy. Participants will undergo detailed thin-slice chest CT scans and pulmonary function tests before surgery. Using Synapse 3-D software, doctors will create patient-specific 3-D lung models to simulate the planned lung tissue removal and calculate the fraction of ventilated lung to be resected. After surgery, patients will follow standard VATS procedures. The study includes long-term follow-up with pulmonary function tests at 3, 6, and 12 months and CT scans at 6 and 12 months to observe structural lung changes. During the study, participants will have preoperative assessments, surgery, and several postoperative visits for lung function tests and imaging. Researchers will measure how closely the predicted lung function matches actual results at 3 months, as well as longer-term accuracy at 6 and 12 months. They will also study how well the remaining lung compensates after surgery and the effect of any complications on recovery. The total participation spans about one year after surgery, allowing detailed evaluation of lung function and recovery.

Researchers are evaluating the safety and effectiveness of different courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel as preoperative (neoadjuvant) therapy in patients with resectable head and neck squamous cell carcinoma (stages T3 or T4, N0). This phase II, prospective, randomized study aims to compare four treatment cycles versus two cycles and assess outcomes such as pathological complete response, adverse events, survival rates, and radiological responses. The study also explores various factors that could influence treatment response and prognosis. Participants are randomly assigned to receive either four cycles or two cycles of pembrolizumab (200 mg IV), carboplatin (300 mg/m2 IV), and albumin-bound paclitaxel (260 mg/m2 IV) every 21 days, followed by surgery. Each treatment cycle occurs on day 1, and continuation depends on absence of disease progression or unacceptable toxicity. The study collects clinical, pathological, imaging, and serological data before and after treatment to evaluate the therapies. During the study, participants undergo assessments including imaging, pathology examination of tumor tissues, and laboratory tests. Researchers monitor adverse events for 90 days post-surgery and measure pathological response six weeks after treatment initiation. Longer-term outcomes such as event-free and overall survival are tracked for up to five years. Data on operation delays and radiographic responses are also gathered to assess treatment safety and efficacy throughout the study duration.

Researchers are evaluating the effects of 5-azacytidine and nivolumab, alone or combined, on HPV-associated head and neck squamous cell carcinoma that can be surgically removed. This Phase 2 trial aims to see if adding 5-azacytidine can make the cancer more responsive to treatment with nivolumab by boosting the immune system's attack on the tumor. The study focuses on patients with specific stages of oropharynx cancer confirmed to be HPV-related and involves measuring immune-related responses in the tumor tissue. Participants are randomly assigned to one of three groups: 5-azacytidine alone, nivolumab alone, or both drugs combined. 5-azacytidine is given intravenously once daily for five days starting on a Monday, with anti-nausea premedication. Nivolumab is administered intravenously twice, either on days 1 and 15 for the nivolumab group or days 2 and 16 for the combination group. Surgery is scheduled shortly after treatment, between days 16 and 18 for the monotherapy groups and days 17 to 18 for the combination group. During the study, patients undergo biopsies before and after treatment to assess tumor response and immune activity. Researchers measure immune-related pathologic response, tumor infiltration by immune cells, tumor size changes, and treatment toxicity. Safety is monitored from the first treatment through 30 days after surgery. Participants provide informed consent and must meet specific health criteria to join. The total involvement includes treatment, surgery, and follow-up assessments to evaluate the treatment effects.

Researchers are comparing two creams to treat low-risk skin cancers, specifically superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). The study evaluates whether a combination cream of 5-fluorouracil and calcipotriene applied for a shorter duration can clear these cancers effectively compared to the standard 5-fluorouracil cream used for 4 weeks. This pilot randomized single-blinded trial is sponsored by Boston University and includes follow-up for up to three years to monitor cancer clearance and recurrence. Participants will be randomly assigned to receive either the combination cream applied twice daily for 7 days, which may be extended to 14 days based on evaluation, or the standard 5-fluorouracil cream applied twice daily for 28 days. The creams are applied to the lesion and a surrounding 0.5 cm area of skin. The study treatments are compared by assessing the clearance of cancer lesions clinically. During the study, participants will have their lesions examined at 3 months and followed for up to 3 years with visits at 6 months and yearly intervals. If lesions are not clearly cleared, biopsies will be performed and standard care will be provided. Researchers will track clearance rates, recurrence, and side effects such as pain, redness, scaling, itching, and burning during treatment. Participant adherence and satisfaction with treatment will also be assessed over the study period.