Clinical trials

This clinical trial tests how well a type of non-invasive brain stimulation called transcranial direct current stimulation (tDCS) works to treat chemotherapy induced peripheral neuropathy (CIPN) in cancer survivors. CIPN is numbness, tingling, pain, and movement problems that can develop after chemotherapy as a result of changes to the nerves. A non-invasive form of brain stimulation called tDCS, applied to the area of the brain involved in sensation and movement, can temporarily improve the ability to detect vibration and temperature, as well as balance and walking, which may improve sensation and reduce pain in cancer survivors with CIPN.

The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic SMA normalizes the levels to those of patients with normal SMA.

* Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS). * Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery. * Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small. * Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival * Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence. * Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after chemotherapy and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence. * A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning.

This clinical trial tests how well a type of non-invasive brain stimulation called transcranial direct current stimulation (tDCS) works to treat chemotherapy induced peripheral neuropathy (CIPN) in cancer survivors. CIPN is numbness, tingling, pain, and movement problems that can develop after chemotherapy as a result of changes to the nerves. A non-invasive form of brain stimulation called tDCS, applied to the area of the brain involved in sensation and movement, can temporarily improve the ability to detect vibration and temperature, as well as balance and walking, which may improve sensation and reduce pain in cancer survivors with CIPN.

This pilot clinical trial is intended to compare the effect of a psychosocial support tool for young adult (YA)cancer survivors - including high-quality information about their cancer combined with evidence-based psychosocial support - to a support tool providing cancer-specific information alone (minus psychosocial modules). This tool, called Thrive Track, will be for YA patients aged 20-39 with thyroid, melanoma, or testicular cancer. Young adult survivors frequently experience persistent worry and distress that can interfere with coping and reduce quality of life. They are also particularly vulnerable to the emotional impact of cancer and may not have adequate support to manage these concerns. The enhanced version of Thrive Track includes personalized emotional support content and strategies designed to help patients better manage worry and distress. Adding these emotional support tools may provide greater benefit than survivorship education alone in strengthening young adult survivors' ability to manage their emotional well-being.

This phase II trial tests how well ivonescimab before surgery works in treating patients with stage II-IV head and neck cancer that can be removed by surgery (resectable). Ivonescimab is a bispecific monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A bispecific monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).

This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments. While there are many approved targeted drugs for ALK NSCLC, resistance to these drugs frequently occur. Giltertinib is a drug that is already FDA approved for the treatment of a specific type of leukemia. However, studies using ALK positive lung cancer cells demonstrate activity of gilteritinib against these resistant cells. Therefore, in this clinical trial, the investigators plan to study the effect of giltertinib in patients with ALK NSCLC.

Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and chemotherapy, and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.

This clinical trial studies whether a virtually delivered diet intervention focused on lower added sugar, higher fiber, and higher omega 3 fatty acid (LASO-3) can be used to improve chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors after treatment. Cancer survivors often experience CIPN during and after cancer treatment with neurotoxic chemotherapy. CIPN is characterized by nerve damage from chemotherapy that leads to numbness, tingling, or pain in the hands or feet. However, there are few treatments to manage CIPN. Inflammation contributes to the development of CIPN and dietary patterns that have been demonstrated to improve diet quality and reduce inflammation in cancer survivors may be promising for use as a CIPN management strategy. The LASO-3 diet intervention consists of virtually delivered nutrition education sessions provided by a Registered Dietitian. The sessions focus on three dietary goals, informed by the United States Dietary Guidelines for Americans: 1) lowering added sugar intake to \< 10% of daily calories, 2) increasing daily fiber intake to ≥ 20 grams, and 3) increasing intake of moderate-high omega-3 seafood to three or more servings weekly or 3300-3400 mg/day of alpha-linolenic acid (e.g., plant-based sources include canola or flaxseed oil, walnuts, or flaxseed or chia seeds). The Registered Dietitian tailors the sessions to the patient based on information and feedback obtained throughout the sessions. The LASO-3 diet intervention may be an effective way to improve CIPN in cancer survivors after treatment.

This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.

This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and/or effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.

This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to genetic testing for relatives of patients with hereditary cancer syndromes. Between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. Some kinds of cancer or certain cancers diagnosed in biological relatives may mean patients are more likely to have a genetic change. Once a genetic change is identified in a family, other biological relatives can choose to undergo testing themselves to better understand their cancer risk. The uptake of genetic testing in other biological relatives once a genetic condition is identified is about 20% to 30%. The Cascade Genetic Testing Platform is a virtual tool that seeks to overcome barriers related to logistics of family communication and improve dissemination of genetic testing information which is clinically actionable for individuals at highest risk for cancer. Using the Cascade Genetic Testing Platform may improve ways to share information about hereditary risk with biological relatives.

This phase I trial tests the safety, side effects and best dose of AdV-HSV1-TK and AdV-Flt3L in combination with valacyclovir for the treatment of patients with primary cancerous (malignant) brain tumors that can be removed by surgery (resectable) and that have come back after a period of improvement (recurrent). AdV-HSV1-TK and AdV-Flt3L use a virus modified in the laboratory to kill tumor cells and stimulate the immune system to recognize the tumor cells as "invaders" which can lead to tumor shrinkage. For this process to work, an oral anti-herpes medication called valacyclovir is also needed. Giving AdV-HSV1-TK, AdV-Flt3L and valacyclovir may be safe, tolerable and/or effective in treating patients with resectable, recurrent primary malignant brain tumors.

This study evaluates urinary biomarkers and PSA to help determine the best approach to early detection of prostate cancer in patients with an elevated familial risk.

This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia/lymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.

This clinical trial tests how well a urine prostate cancer screening test, My Prostate Score 2 (MPS2), integrated with magnetic resonance imaging (MRI) works for early detection of prostate cancer. MPS2 is an investigational urine-based test designed to help identify the likelihood of having aggressive prostate cancer. MPS2 testing works by measuring specific early detection biomarkers that include genetic information. This next-generation test aims to address a major challenge in prostate cancer care-detecting only the cancers that truly need treatment. Results may lead to paradigm shifts in early detection algorithms and reduce reliance on MRI and biopsy.

This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma. Ureteroscopy is traditionally performed in an operating room under general anesthesia. In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind. Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis. Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.

This clinical trial studies whether a web-based program, Kindred, works to improve the understanding of genetic cancer risk and cancer genetic testing in African American families. Between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. Some kinds of cancer or a family history of cancer means individuals are more likely to have a genetic change. If a genetic change is identified in a family, other relatives can choose to undergo hereditary cancer genetic testing to better understand their cancer risk. In families where a genetic change is not identified, or results are uncertain, relatives may also benefit from discussing their cancer risk with providers and, in some cases, getting hereditary cancer genetic testing themselves. Research has shown that African Americans are less likely than other racial groups to engage in cancer genetic testing. Kindred is an online tool that provides information so individuals can learn about their cancer genetic test results, how cancer genetic testing can help individuals and families understand their overall cancer risk (and strategies for reducing risk), and ways to talk with each other about cancer risk and health. This may be an effective way to improve the understanding of genetic cancer risk and cancer genetic testing in African American families.

The purpose of this phase 1a/b trial is to find out what amount of exercise would be best to use for preventing recurrence of colorectal polyps. It involves following one of four different amounts of exercise regimens on a treadmill for 26 weeks. A treadmill will be placed in each study participant's home for the duration of the study. The exercise regimen will be personalized for each participant and monitored remotely by exercise personnel. The in-person study visits occur during the usual standard of care endoscopy exam and during a follow-up exam that is 26 weeks later. Small rectal tissue biopsies, about the size of a grain of rice, will be taken before and after 26 weeks of exercise. The study visits also involve questionnaires, a stool sample, and a blood sample. This study will inform the design of larger, future trials to investigate whether or not recurrence of polyps can be achieved with exercise.

Colon cancer is the second most common cancer in men and women. It is a disease that can be prevented if it is found early. Colonoscopy is still the best screening tool for colon cancer and the polyps that turn into colon cancer. However, due to a variety of factors, including affordability, time, and age, not all patients are able to be screened. Researchers are working on other options for early detection that are as accurate as colonoscopy. The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.

This is an open-label, single-arm, multicenter, phase II study combining pembrolizumab and mogamulizumab in patients with advanced-stage, relapsed or refractory CTCL Each cycle will equal 6 weeks. Pembrolizumab will be administered on Day 1 of each cycle. Mogamulizumab will be administered on Day 1, 8, 15, and 22 of Cycle 1. For Cycle 2 and subsequent cycles, mogamulizumab will be administered on Day 1, 15 and 29 of each cycle. Subjects will undergo a response assessment prior to Cycle 3 and every 2 cycles thereafter. Subjects will continue study treatment until documented progression, unacceptable toxicity, or any other condition for discontinuation is met in protocol. A maximum of 2 years of study treatment may be administered. If a subject achieves a complete response (CR) per mSWAT criteria after 3 months of study treatment (2 cycles), they will continue study therapy for an additional 6 months (4 cycles). If a confirmed and persistent CR is met, they may discontinue study treatment and enter an observation period in protocol. Repeat disease evaluation is required prior to study therapy discontinuation. Subjects who progress during the observation period may be eligible for up to an additional 9 cycles (1 year) of pembrolizumab and mogamulizumab.

To assess the feasibility and preliminary effectiveness of a Cardio-Oncology Prehabilitation program in patients at high-risk of developing Cardiovascular (CV) events in improving Cardiorespiratory fitness (CRF) and reducing acute CV complications in Hematopoietic stem cell transplant (HSCT) recipients.

This phase I/II tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow. Enzalutamide, an androgen receptor inhibitor, works by blocking the effects of androgen (a male reproductive hormone). This may help stop the growth and spread of tumor cells that need testosterone to grow. Giving ruxolitinib in combination with enzalutamide may be safe, tolerable, and/or effective in treating metastatic castration-resistant prostate cancer.

This phase II trial tests the safety and effectiveness of a dietary supplement called resistant potato starch for reducing musculoskeletal symptoms in patients with stage 0-III breast cancer or who are at high risk for breast cancer and are planning to receive treatment with an aromatase inhibitor. Aromatase inhibitors are a type of drug commonly used for the treatment or prevention of breast cancer. Many people who receive aromatase inhibitors experience musculoskeletal symptoms (symptoms relating to bones and muscles, such as joint pain or stiffness). Research has shown there may be an association between reduced levels of beneficial gut bacteria and the development of aromatase inhibitor-associated musculoskeletal symptoms. Resistant potato starch is a plant-based low-digestible carbohydrate that has the potential to promote the growth of beneficial gut bacteria. Taking resistant potato starch while receiving aromatase inhibitor therapy may reduce musculoskeletal symptoms in patients with stage 0-III breast cancer or individuals at high risk of developing breast cancer.

Participants will be randomly assigned to either the intervention or control group using concealed allocation. The intervention-comprising targeted educational materials and behavioral prompts-will be delivered over three months preceding race day. All study participants will be required to complete the pre-race survey prior to the intervention. The intervention group will complete the SunBeast Educational module once and receive monthly reinforcement messages leading into race day. The SunBeast Educational Program module consists of a 30-minute live, interactive online discussion and infographics/videos on skin cancer, UV index awareness, sunscreen use, protective clothing, and timing of runs. The control group will receive a general wellness brochure via email. The general wellness brochure will contain UV protection information but will also have other general wellness topics.