Pahrump

Researchers are evaluating the combination of nivolumab and blinatumomab compared to blinatumomab alone in patients aged 1 to under 31 years with first relapse of CD19+ B-cell acute lymphoblastic leukemia (B-ALL), including those with Down syndrome. This phase II trial aims to compare event-free survival and remission rates, as well as assess safety and tolerability of these treatments in this patient group. Treatment involves several groups and arms with different combinations of drugs including dexamethasone, blinatumomab, nivolumab, methotrexate, and others. Some groups receive pre-immunotherapy treatments depending on disease characteristics. Treatment cycles last about 36 to 37 days and may repeat up to two cycles unless disease progression or unacceptable toxicity occurs. Radiation therapy and various chemotherapy regimens are also part of the treatment for certain patients. Participants undergo lumbar punctures, bone marrow biopsies and aspirations, and collections of blood, urine, and cerebrospinal fluid throughout the study. After treatment completion, they are followed up every 3 months for 1 year. The main results measured include minimal residual disease-negative remission rates and event-free survival. Safety, adverse events, and other clinical factors are closely monitored during and after treatment.

Researchers are evaluating how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.

Researchers are evaluating the addition of olaparib, a targeted therapy that blocks the PARP enzyme involved in DNA repair, in patients with pancreatic cancer who have had surgery to remove their tumor and carry a mutation in BRCA1, BRCA2, or PALB2. This phase II trial aims to determine if olaparib can improve relapse-free survival compared to placebo after chemotherapy completion. The study also explores overall survival and differences based on mutation type and chemotherapy received. Participants are randomly assigned to one of two groups. One group receives oral olaparib twice daily for 28-day cycles, up to 12 cycles, while the other group receives a placebo on the same schedule. Throughout treatment, patients undergo CT or MRI scans and blood collection. After treatment, patients are followed for up to 10 years with regular visits to monitor health and disease status. During the study, participants complete imaging scans and blood tests to assess disease progression and treatment effects. Researchers track relapse-free survival from the time of randomization until disease recurrence or death, with assessments extending up to 44 months. Safety and survival outcomes are monitored for up to 10 years. Follow-up visits occur 30 days after treatment and then every 4 months in the first year, followed by every 6 months for years 2 through 10.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients' medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

Researchers are investigating treatments for patients with metastatic kidney cancer, focusing on whether adding surgery to a standard immunotherapy-based drug combination improves overall survival. This phase III trial compares outcomes for patients receiving immunotherapy with or without surgery to remove the kidney, known as nephrectomy. Immunotherapy drugs like nivolumab, ipilimumab, pembrolizumab, and avelumab aim to help the immune system attack the cancer, while axitinib works to block tumor growth. The benefit of adding surgery to these drug treatments is not yet established. Participants first receive one of three standard immunotherapy-based regimens before randomization, including combinations of intravenous nivolumab, ipilimumab, pembrolizumab, avelumab, and oral axitinib. After about 10 to 14 weeks of this initial treatment, patients are randomly assigned to continue systemic therapy alone or to receive surgery to remove the kidney plus the same systemic therapy. Surgery may be radical or partial and performed using laparoscopic, open, or robotic methods within 8 weeks of randomization. Axitinib is paused before surgery and resumed after recovery. Throughout the study, participants undergo scans and clinical assessments to monitor tumor response and side effects. After completing treatment, patients are followed up every 3 months during the first year, then every 6 months for years two and three, and annually thereafter for up to seven years. The trial measures overall survival, tumor response in metastatic sites, changes in tumor size, and complications from surgery or drug toxicities. Specimens are also collected for future research to better understand the disease and treatments.

Researchers are evaluating the impact of the Cost Communication and Financial Navigation (CostCOM) program on how well cancer patients stick to their treatment plans and manage financial stress. Many people with cancer face financial difficulties due to high out-of-pocket costs and changes in employment or insurance, which can cause delays or interruptions in care and lower quality of life. This study compares CostCOM with enhanced usual care to see if it helps reduce financial hardship and improve care adherence and patient satisfaction. Participants are randomly assigned to one of two groups. One group receives a brochure about financial navigation services from the Patient Advocate Foundation. The other group receives standard financial care plus CostCOM financial counseling sessions lasting about an hour, given within 30 days of enrollment and again at 3, 6, and 12 months. Non-patient participants, such as providers or coordinators, may take part in surveys and interviews to share their experiences with the CostCOM program. Patients will be followed for 12 months after completing the intervention. During this time, they will complete surveys about their adherence to cancer care, financial hardship, worry, quality of life, and satisfaction with care at several points. Researchers will also assess the accuracy of cost estimates given to patients and explore neighborhood characteristics. The study includes interviews and surveys with non-patient participants conducted 15 to 39 months after the first patient enrollment.

Researchers are evaluating whether adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups: one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigator’s discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients’ health and quality of life.

Researchers are studying the effects of social and genetic factors on the health outcomes of adolescent and young adult (AYA) cancer survivors who had Hodgkin or non-Hodgkin lymphoma. This observational study aims to understand how these factors influence disease-free survival, overall survival, and quality of life in this group, which faces unique risks compared to older or childhood cancer patients. The study also explores how gene expression changes might mediate these effects and considers the impact of race, gender identity, and location. Participants will complete questionnaires about their health-related quality of life and provide blood samples at the start of the study and then at 6, 12, 18, and 24 months. These activities will help researchers gather information on social-environmental risk factors, individual resilience, and biological changes. The study does not involve any treatment but focuses on monitoring and collecting data over two years. During the study, participants will be asked to complete quality of life questionnaires and give blood samples multiple times. Researchers will track disease-free survival, overall survival, and any other health complications up to two years. The study includes careful monitoring of participants' health status and aims to provide insights that could help improve care for young cancer survivors. Participation requires internet access and the ability to complete forms in English, with informed consent obtained from each participant or their representative.

This research aims to assess colorectal cancer rates in participants aged 45 to 70 who have 1 to 2 non-advanced adenomatous polyps. The study compares the outcomes of surveillance colonoscopy performed once at 10 years versus twice at 5 and 10 years after the initial colonoscopy. Colorectal cancer is a common and serious disease, and while colonoscopy screening reduces its incidence, the best timing for follow-up exams after finding small non-advanced adenomas is unclear. Participants are randomly assigned to one of two groups: one group receives surveillance colonoscopies at both 5 and 10 years after the qualifying colonoscopy, and the other group receives a single surveillance colonoscopy at 10 years. Colonoscopies follow standard quality guidelines and preparation instructions. All polyps found during the initial colonoscopy must have been completely removed for participants to be eligible. Throughout the study, participants will undergo colonoscopies according to their group assignment and will be monitored for the development of colorectal cancer over 10 years. Researchers will evaluate the incidence of colorectal cancer as the primary outcome. Participants' adherence to scheduled colonoscopies and any additional procedures will be tracked. This study is designed to provide clear evidence on the optimal timing of surveillance colonoscopy after detection of small adenomas, informing future guidelines and clinical practice.