Bonne Terre

This trial investigates monitoring and treatment options for patients with low risk and standard risk metastatic germ cell tumors, which are cancers that start in the cells that produce sperm or eggs. The study aims to find out if active surveillance after surgical removal of low risk tumors can maintain high survival rates, and whether carboplatin or cisplatin chemotherapy works better for treating standard risk tumors in children, adolescents, and young adults. Patients with low risk tumors undergo observation after surgery and may transfer to a standard risk treatment arm if the tumor recurs. Those with standard risk tumors are randomly assigned to receive one of two chemotherapy regimens one containing carboplatin, bleomycin, and etoposide, or the other containing cisplatin, bleomycin, and etoposide. Treatments are given intravenously in cycles every 21 days for up to 3 or 4 cycles depending on the group. Throughout the study, patients have imaging scans, blood tests, tumor biopsies, and pulmonary function tests to monitor response and side effects. Participants are followed closely during treatment and afterward with regular check-ups including CT, MRI, and chest X-rays, as well as blood sample collections. Follow-up visits occur every 2 months for the first year, then every 3-6 months up to 2 years, every 6 months for years 3 to 5, and annually up to 10 years. Researchers measure overall survival, event-free survival, hearing loss, body composition, tumor markers, and patient-reported outcomes related to hearing and neuropathy. This long-term monitoring helps assess the effects and safety of chemotherapy and surveillance strategies.

Researchers are collecting and storing tissue and blood samples from patients with various types of cancer to help create better models for studying cancer and testing new cancer drugs. This observational study focuses on patients with hematopoietic and lymphatic system neoplasms, malignant solid tumors, metastatic malignant solid tumors, and recurrent malignant solid tumors. The goal is to procure biological tissues and materials to develop preclinical cancer models for future laboratory analysis. During the study, tumor tissue and blood samples are collected during medical procedures required for the patients cancer treatment. These samples are then preserved using methods such as xenograft models, where tissues are transplanted to another species, or in vitro cell cultures. This process allows for future scientific study without additional invasive procedures beyond routine clinical care. Participants will be involved in routine clinical procedures during which tissue and blood samples are collected. Researchers will store these specimens and monitor their use in creating cancer models over a period of up to five years. The main outcome measured is the successful procurement and storage of tissue and blood specimens for research purposes. Participation will continue as long as samples can be collected during clinical management, with no additional treatment or interventions required specifically for this study.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating how well radiation therapy with or without the chemotherapy drug cisplatin works in treating patients who have stage III-IVA squamous cell carcinoma of the head and neck after surgery. This phase II trial aims to understand if adding cisplatin to radiation therapy improves disease-free survival and to explore the role of p53 mutations as a biomarker for treatment benefit. The study also assesses the safety and side effects of these treatments and looks for other genetic changes that might guide new therapies. Participants are randomly assigned to one of two groups. One group receives intensity-modulated radiation therapy IMRT once daily, five days a week for six weeks. The other group receives the same radiation schedule plus weekly intravenous cisplatin for six weeks. After treatment, participants are followed up every six months for three years and then yearly for seven years to monitor outcomes. During the study, patients will have assessments including surgical tumor tissue analysis for p53 mutation, imaging scans to check for cancer spread, and blood tests to monitor health and organ function. Researchers will track disease recurrence, new tumors, or death for up to 10 years. Side effects will be recorded during treatment. The total study participation includes treatment over six weeks followed by long-term follow-up visits lasting up to 10 years.

Researchers are evaluating patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based therapy and are at risk of heart problems. The study includes two groups one large observational group taking beta blockers, ACE inhibitors, or ARBs alongside trastuzumab, and a smaller randomized group comparing the effects of carvedilol versus no treatment. The aim is to understand the occurrence of heart issues and whether carvedilol might help prevent cardiac side effects from chemotherapy. Participants are assigned to one of three arms based on their current medications. Patients not on beta blockers, ARBs, or ACE inhibitors are randomized to either receive carvedilol orally twice daily or no study intervention. Those already taking these heart medications enter an observational arm without additional treatment. Treatment and observation continue for up to 108 weeks unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo heart function monitoring with echocardiograms every 12 weeks and provide blood samples for biomarker analysis. Researchers track the time to the first sign of heart dysfunction and any cardiac events, as well as adherence to medication and side effects. The study also collects data to develop models predicting heart risk and banks samples for future research. Participant involvement may last over two years with regular assessments to monitor safety and heart health.

Researchers are evaluating how well serum tumor marker directed disease monitoring STMDDM works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.

Researchers are evaluating how well osimertinib works in treating patients with advanced non-small cell lung cancer NSCLC that has a specific EGFR exon 20 insertion mutation. This includes patients with stage IIIB-IV disease or those whose cancer has returned after improvement. The study is a phase II trial aiming to understand the tumor response and safety profile of osimertinib in this group. Researchers also want to explore molecular and genetic markers related to treatment response and resistance. Participants receive osimertinib orally once daily in 21-day cycles, continuing until the cancer worsens or side effects become unacceptable. During treatment, patients have imaging tests like echocardiography or MUGA scans, MRI or CT scans with contrast, and blood samples collected to monitor their health and disease. After stopping treatment, patients are followed for 30 days and then every three months for up to five years to assess long-term outcomes. Throughout the study, researchers measure the best tumor response, progression-free survival, overall survival, and any side effects experienced. They also analyze blood and tumor samples to study molecular markers and resistance mechanisms. The total participation can last up to five years, including treatment and follow-up periods, with regular imaging and laboratory assessments to track the disease and patient safety.

Researchers are evaluating the effectiveness of combining cabozantinib with two immunotherapy drugs, nivolumab and ipilimumab, in treating patients with rare genitourinary tumors that have spread beyond their original site. This phase II study focuses on patients with various rare histological types of genitourinary cancers, aiming to assess how well this combination works compared to using each drug alone. The trial also aims to understand the safety of this treatment and to collect tissue samples and clinical data for further research. Participants receive cabozantinib orally once daily on days 1-21 of the first four cycles and continuously on days 1-28 of subsequent cycles. Nivolumab and ipilimumab are given intravenously on day 1 of the first four cycles, with nivolumab continuing as an IV infusion on day 1 of later cycles. Each treatment cycle lasts 21 days initially and 28 days thereafter, continuing for up to two years unless the disease progresses or unacceptable side effects occur. Patients may have scans such as CT, MRI, bone scans, and PETCT during the study and undergo blood and urine sample collections. Echocardiography is performed during screening. Throughout the study, participants are monitored with imaging tests and sample collections to track tumor response and safety. After completing treatment, patients have follow-up visits every two months for up to five years to observe long-term effects and survival. The main measure of success is the objective response rate, with additional assessments of progression-free survival, overall survival, clinical benefit, and adverse events. This extended monitoring helps researchers understand the lasting impact of the treatment combination.

Researchers are evaluating the effects of several targeted drugsvismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclibon patients with progressive meningiomas. These tumors are growing, spreading, or worsening, and the study focuses on different genetic mutations in the tumors to match patients with the appropriate drug. The trial is a phase II study aiming to measure progression-free survival and response rates over six months, along with overall survival and adverse events. Participants are assigned to one of four groups based on their tumor mutation status. Those with SMOPTCH1 mutations receive vismodegib daily those with NF2 mutations receive FAK inhibitor GSK2256098 twice daily patients with AKT1, PIK3CA, or PTEN mutations take capivasertib twice daily on days 1-4 weekly and those with CDK pathway alterations receive abemaciclib twice daily. Treatment cycles repeat every 28 days as long as the disease does not progress or unacceptable side effects occur. After treatment, participants are followed every six months for up to five years. During the study, patients undergo regular monitoring including imaging to assess tumor size and progression, lab tests to monitor blood counts and organ function, and evaluations of side effects. Researchers track progression-free survival at six months and tumor response rates, as well as overall survival. Safety is closely observed up to four weeks after treatment ends. The total study duration includes active treatment cycles and long-term follow-up extending up to five years from registration.