Clinical Research Directory

Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)

This phase II MATCH treatment trial identifies the effects of copanlisib hydrochloride (copanlisib) in patients whose cancer has a genetic change called PIK3CA mutation. Copanlisib may stop the growth of cancer cells by blocking PIK3, a protein needed for cell growth. Researchers hope to learn if copanlisib will shrink this type of cancer or stop its growth.

NCI COVID-19 in Cancer Patients, NCCAPS Study

This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness

This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone.

Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters

This phase II randomized, placebo-controlled trial evaluates whether daily supplementation with broccoli seed and sprout extract (BSSE), also known as Avmacol Extra Strength (ES), enhances the body's natural ability to detoxify carcinogens commonly encountered by firefighters. Firefighters are routinely exposed to harmful chemicals such as benzene and polycyclic aromatic hydrocarbons (PAHs) through smoke inhalation, structural fires, and fuel leak incidents exposures that contribute to their elevated cancer risk. BSSE contains bioactive compounds known to activate phase II detoxification enzymes that help eliminate reactive toxins from the body. A single dose of acetaminophen (Tylenol) is administered at both baseline and end-of-intervention as a metabolic probe to assess changes in detoxification enzyme activity. Acetaminophen is metabolized through the same pathways as benzene and PAHs, making it a useful surrogate for evaluating the effect of BSSE on the detoxification of fire-related toxicants. Participants were originally randomized into one of total four study groups. Groups I and II, now closed to accrual, were designed to assess BSSE effects before and after controlled flashover fire training exercises. These arms were discontinued after it was determined that training fires produced insufficient real-world toxicant exposure to evaluate the intervention's impact. Groups III and IV were subsequently open and represent the active phase of the study. Group III participants receive BSSE daily for 12 weeks, while Group IV participants receive a matched placebo. Both groups include acetaminophen challenge at baseline and end-of-intervention, with biospecimen collection to evaluate detoxification capacity and explore genetic and epigenetic modifiers of response. Although the protocol includes four study groups, only two are currently active. Groups I and II remain part of the study record but are closed and will not contribute to the primary outcome analyses.

Understanding Needs of Older Patients Prior to Starting Cancer Treatment

A geriatric assessment (GA) is a structured approach to identifying and addressing the strengths and vulnerabilities of older adults with cancer. They can improve the quality of cancer care for older adults and lower side effects. It is recommended a GA be administered prior to the start of non-hormonal systemic therapy for all older adults. Despite these guidelines, only a small percentage of practices report administering them. The practical geriatric assessment (PGA) was developed to help oncology practices perform GAs. It aims to provide a brief way to evaluate older patients' physical health along with other important things like support network and impact to the patient's daily life. Typically, clinics do not receive extra training on delivering the PGA. Providing training and support for staff at cancer clinics may help deliver the enhanced PGA to older adult cancer patients who are starting a new-hormonal systemic therapy. This clinical trial looks at whether providing training and support for staff at cancer clinics can help them deliver patient check-ups (e.g., PGA) specifically designed for adults \>= 65 years old (older adults) starting a new non-hormonal systemic cancer therapy. The usual approach clinics use when starting these cancer therapy courses with an older adult may vary considerably.

Distance-Based Exercise to Preserve Function and Prevent Disability

This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.

Virtual Reality for Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation

This clinical trial compares the use of virtual reality to standard care for improving symptom management in patients undergoing hematopoietic stem cell transplantation (HSCT). Significant symptoms experienced by hospitalized HSCT patients include, but are not limited to, depression, tiredness, anxiety, drowsiness, lack of appetite, pain, and overall decreased quality of life and well-being. Virtual reality (VR) as an intervention can provide these patients with a much-needed escape from their reality and has proven results in clinical settings as a distraction therapy. VR technology targets the patient's auditory, visual, and physical contact/touch senses, and has been evidenced to improve depression, fatigue, anxiety, appetite, and pain. Virtual reality may improve symptom management in patients undergoing HSCT.

Telephone-Based Coaching Sessions (TAC) to Improve Advance Care Planning Participation in Advanced Cancer Patients and Their Support Person

This clinical trial studies whether telephone-based coaching sessions, Talking About Cancer (TAC), work to improve engagement in advance care planning (ACP) in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and their support person. Participation in ACP, which includes having end of life (EOL) care conversations and completing advance directives (e.g., living will, health care proxy, do not resuscitate order), improves quality EOL care. Despite this, less than half of patients with advanced cancer have EOL care conversations or complete advance directives. TAC coaching sessions are delivered by a social worker over the phone. They are designed to help patients and their support person communicate about ACP, manage the distress these conversations can cause, and participate in the process of ACP with a clear action plan of having goals-of-care conversations and completing advance directives. This may be an effective way to improve ACP participation in advanced cancer patients and their support person.

CREATE: Art for Children With Cancer

This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer.

Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial

This clinical trial tests the feasibility, usability and acceptability of a virtual art therapy assisted re-integration (AVATARS) intervention to improve biopsychosocial outcomes, such as anxiety, depression, resilience, emotional regulation, stress, and cognition, among adolescent and young adult (AYA) cancer survivors. AYA cancer survivors (especially those treated at adult cancer centers) historically experience worse psychosocial outcomes and lack age appropriate psychosocial support compared to older adult cancer survivors. Creative art therapy accesses the limbic system to provide a corrective emotional experience in response to trauma and can help patients visually express depression, anxiety, and existential fears, process traumatic events, and regain agency and control. The AVATARS intervention may be a feasible, useable and acceptable way to improve biopsychosocial outcomes among AYA cancer survivors.

Patient Interest in an Integrative Oncology Program at USC Norris Cancer Center: A Single-Institution Needs Assessment

This study assesses patient perspectives on the interest in, feasibility, and acceptability of an Integrative Oncology Program for patients at USC NCCC and HC3 Women's Clinic.

A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant

This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and/or effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.

Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies

This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incurable). For patients with metastatic, incurable cancer, unrelieved anxiety and existential distress can cause profound suffering. Psilocybin therapy can relieve anxiety and existential distress by disrupting patterns of thinking that contribute to anxiety and depression. Psilocybin is a substance being studied in the treatment of anxiety or depression in patients with cancer. In this study, a pharmaceutical grade of psilocybin will be used that has been approved by the FDA for research, provided by Filament Health. Psilocybin acts on the brain by resetting the brain's activity and increasing connections between brain regions, particularly those involved in mood regulation and self-perception. In this study psilocybin is combined with structured discussions and reflections that enable patients to have new insights about their situation. In a prior study, group retreat psilocybin therapy was proven to be safe and this study tests a refined dosing regimen for symptoms of anxiety and depression in patients with metastatic solid tumors or incurable hematologic malignancies.

Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids

This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). This may impact a patient's "total pain", a view that accounts for the psychological, spiritual, and social factors that contribute to their experience of pain. Psychotherapy uses methods such as discussion, listening, and counseling to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain.

Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers

This clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. Caregivers of patients receiving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC) demonstrate that they endure high depressive symptom burdens and financial distress. Further, they experience symptom trajectories that differ from those of patients. In short, they require differential timing of supportive interventions. This study aims to reduce financial toxicity and distress levels and to increase self-efficacy, satisfaction and engagement with care. Information gathered from this study may help researchers determine whether telehealth interventions for caregivers may increase awareness of recommended resources that could be beneficial during caregivers journey.

Ambient Sensing Room to Detect Early Signs of Adverse Events in Hospitalized Patients With Cancer

This study uses ambient sensing rooms to collect data from hospitalized cancer patients in order to improve safety and recovery. Being hospitalized increases the risk for delirium (acute confusion), falls, troubles sleeping, and mood changes. Ambient sensing rooms are special rooms that use technology including a video camera to watch the room, an audio recorder to listen to sounds, and a temperature sensor (thermography) to check how warm or cool the room and people are. These tools may help nurses and doctors notice problems early, give better care, and keep patients safe and comfortable.

A Culturally Informed Patient Navigation Program (CFPN) to Reduce Delays Between Diagnosis and Treatment in American Indian and Alaska Native Cancer Patients Living in Rural California

This clinical trial develops and tests whether a culturally informed patient navigation program, Community-Focused Patient Navigation (CFPN), works to reduce delays between diagnosis and treatment in American Indian and Alaska Native (AIAN) cancer patients living in rural California. AIAN communities face some of the most severe cancer disparities in the United States, including higher death rates, later-stage diagnoses, and limited access to timely, culturally responsive care. This may be due to barriers such as rural isolation, divided referral systems, or a lack of trust in mainstream healthcare systems. Patient navigation is a care delivery model designed to guide a patient through the healthcare system and address the barriers that prevent patients from accessing timely and effective care. The CFPN program is culturally tailored and designed with AIAN communities in mind. The program provides the patient with a treatment plan based on the patient's unique needs, goals, and barriers. This may be an effective way to reduce delays between diagnosis and treatment in AIAN cancer patients living in rural California.

Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation

This study evaluates the factors that contribute to chronic graft-versus-host disease, which is a complication that can occur after allogeneic hematopoietic cell transplantation.

Data-Driven Strategies for Patient Engagement About Cancer Clinical Trials

This study assesses patient awareness and understanding of cancer clinical trials.

Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors

This clinical trial evaluates whether a supervised community-based exercise and nutrition program is usable and effective for improving cancer survivors' confidence for maintaining their physical activity and nutrition. Cancer survivors often experience problems with the musculoskeletal system (bones, joints, muscles, connective tissue), the cardiopulmonary system (heart, blood vessels and lungs) and the metabolic system (how the body's cells change food into energy) following treatment. There is substantial evidence that physical activity, diet, and weight management can improve quality of life (emotional and physical well-being) and physical fitness. Information gathered from this study may help researchers determine whether participating in a community-based exercise/nutrition training and education program may improve levels of fitness, cardiovascular health, and quality of life for cancer survivors.

Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies

This clinical trial examines sustained oral fiber supplementation for patients undergoing donor stem cell transplantation for hematological malignancies. Patients undergoing donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. Oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and/or improve gut function in patients undergoing stem cell transplants.

Collection and Storage of Tissue and Blood Samples From Patients With Cancer

This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.

Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study

This study explores the potential value of a new blood test approach for early detection of cancer.

A Virtually Delivered Diet Intervention (LASO-3) for the Improvement of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors Post-treatment

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.