Sidney

Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in patients with stage III-IVA squamous cell carcinoma of the head and neck who have had surgery to remove their tumors. This phase II trial aims to understand if adding cisplatin to radiation therapy improves disease-free survival, especially considering the role of p53 mutations in the cancer cells. The study also investigates toxicities and potential genomic factors that might influence treatment outcomes. Patients are randomly assigned to one of two treatment groups. One group receives intensity-modulated radiation therapy (IMRT) alone once daily, five days a week for six weeks. The other group receives the same radiation treatment combined with weekly intravenous cisplatin over one to two hours, also for six weeks. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants undergo regular follow-ups every six months for three years and then yearly for seven more years to monitor for cancer recurrence or new tumors. Researchers assess disease-free survival, tracking the time from randomization until cancer returns, a second tumor develops, or death. Additional laboratory tests and biomarker analyses are performed to understand genetic changes and treatment effects. Safety and toxicities are closely monitored throughout the study period.

Researchers are evaluating the effects of several targeted drugs—vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib—on patients with progressive meningiomas that have specific genetic mutations. This phase II trial focuses on tumors that are growing, spreading, or worsening despite prior treatment. The study aims to measure how well these drugs work in slowing tumor progression and improving response rates, especially in patients whose tumors have mutations in SMO, PTCH1, NF2, AKT1, PIK3CA, PTEN, and CDK-related pathways. Patients are assigned to one of four treatment groups based on their tumor's genetic mutation profile. Those with SMO or PTCH1 mutations receive vismodegib daily by mouth, those with NF2 mutations receive the FAK inhibitor GSK2256098 twice daily, patients with AKT1, PIK3CA, or PTEN mutations take capivasertib twice daily for four days each week, and those with CDK pathway alterations receive abemaciclib every 12 hours. Each treatment cycle is 28 days, continuing unless the disease worsens or side effects become unacceptable. After treatment ends, patients are followed every six months for up to five years. Participants undergo various assessments including imaging scans and genetic testing to confirm eligibility and monitor tumor status. Researchers track progression-free survival at six months and response rates up to two years. Safety is monitored through adverse event reporting and lab tests. The study also collects data on overall survival and treatment tolerability. Patients are carefully evaluated before and during treatment to ensure safety and measure the drugs' effects on tumor growth and patient health over time.