Clinical Research Directory

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

The Vanguard Study: Testing a New Way to Screen for Cancer

The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).

Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)

This study evaluates the effectiveness of robotic biopsies in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.

Testing the SurVaxM Vaccine for Lung Cancer Prevention

This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients. Upon administration, the SurVaxM vaccine activates the immune system to produce an immune cell response against cancer cells that express a protein called survivin. This may result in decreased tumor cell proliferation and lead to tumor cell death. SurVaxM is given with montanide, a substance that helps the immune system respond to the SurVaxM vaccine, followed by sargramostim, which is given to increase the number of white blood cells in the body. The SurVaxM vaccine may help the body make special proteins called antibodies, which may be helpful in preventing the development of lung cancer.

Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington State, SACRED LUNGS Trial

This clinical trial studies whether tailored patient navigation (PN) works to improve the uptake of lung cancer screening (LCS) in tribal communities in western Washington state. Lung cancer is the leading cause of cancer death in the United States among American Indian (AI) and Alaska Native (AN) people, and the incidence of lung cancer is higher in this population in the Northern and Southern Plains, Alaska, and Pacific Coast regions. In Washington state, AI/AN people also have twice the rate of commercial cigarette smoking than the overall population. LCS with annual low-dose chest computed tomography (CT) can reduce lung cancer death and is recommended in people 50-80 years of age with current or recent (within 15 years) tobacco use and a 20 pack-year or greater smoking history. Despite this, AI and AN people are less likely to receive LCS which may be due to barriers they face making it difficult to receive LCS. PN services are designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN services in this trial have been tailored for the tribal communities in western Washington state. The services are designed to help participants overcome the unique barriers that their tribal communities face and improve the uptake of LCS.

Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues

This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.

A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to Increase Lung Cancer Screening Among Black Community Members, RESTORE Trial

This clinical trial develops and studies whether a restorative justice-based lung cancer screening (LCS) decision-making support intervention tailored for Black individuals increases LCS among Black community members. Lung cancer remains the leading cause of cancer deaths among Black men and women. LCS with yearly low-dose chest computed tomography (CT) is recommended for people with current or recent tobacco use (within 15 years) who are aged 50-80 with at least a 20 pack-year smoking history. LCS lowers lung cancer death by 20%; however, data shows that LCS completion remains low among minority groups in the United States. The restorative justice-based LCS decision-making support intervention in this trial has been specifically tailored to meet the needs of Black individuals. It is designed to reduce racial unfairness by promoting trust, shared understanding, and empowerment in clinical decision making while addressing the social and historical circumstances of health inequalities. This may be an effective way to increase LCS among Black community members.

Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer

This pilot phase I/II trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (SBRT) for lung cancer. The continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. Deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. Using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.

Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer

This clinical trial investigates the effects of switching from smoking regular cigarettes to electronic cigarettes (e-cigarettes) among older adult smokers at high risk for lung cancer. E-cigarettes use heated vapor to deliver nicotine. Information gained from this trial may help inform regulators of the potential risks and benefits of switching smokers at high risk for lung cancer to electronic cigarettes. This research also may help inform the Food and Drug Administration (FDA) how best to regulate e-cigarettes with the goal of improving public health.

MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer

This pilot phase I trial studies the side effects and how well MUC1 peptide-Poly-ICLC vaccine works in preventing lung cancer in current and former smokers at high risk for lung cancer. Vaccines made from peptides may help the body build an effective immune response to kill cells. MUC1 peptide-Poly-ICLC vaccine may stimulate the body's immune system and slow or stop the changes from normal to pre-cancer to cancer.

Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction

This phase I trial studies the side effects and the best dose of veliparib when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with paclitaxel and carboplatin may kill more tumor cells.

The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas

This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.

Screening for Lung Cancer in Older Patients (PLCO Screening Trial)

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer.

A New Way to Share Radiation Therapy Plans Between Doctors, CORRECT Trial

This clinical trial tests a new way to share radiation therapy plans using the Collaborative Oncology between Radiologists and Radiation oncologists for the Evaluation of Contoured Targets (CORRECT) workflow to improve communication and collaboration between radiation oncologists (ROs) and radiologists when determining cancer targets for radiation treatment. Systemic barriers limit critical communication between radiation oncologists and radiologists and can lead to both under and overdosing of radiation therapy (RT) tumor targets and failures to properly interpret post-treatment imaging. The limited formal diagnostic radiology training of many providers can make differentiating normal from disease imaging findings during target determination difficult, especially in complex disease sites like the lung, head, and neck. Inaccurate target determination may result in cancer return, excess toxicity, or both. Likewise, radiologists who cannot access prior RT plans may mistake expected RT changes for recurrent cancer or overlook true progression. The CORRECT workflow was developed by ROs and radiologists to address RO-radiology communication barriers by facilitating sharing of comprehensive RT target contours during RT planning. The CORRECT workflow begins with the normal process of RO target contouring. Computed tomography (CT) images are then fused with RT targets and pushed to a pre-designated Picture Archiving and Communications System (PACS) software folder accessible by the radiology department. The radiologist can then review the fused images at their chosen time and annotate images to indicate potential deviations (e.g., not avoiding normal tissue or not including all tumor). The RO reviews the annotated images and decides if any changes to treatment targets are needed for the final treatment plan. Through this independent, asynchronous review of high-quality images, CORRECT overcomes many of the limitations of existing communication methods between RO-radiologist, fostering a more collaborative, efficient, and precise approach to cancer treatment planning.

Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting

This trial assesses current biomarker testing practices for common solid cancers in precision oncology in the community setting. Cancer biomarkers are used for diagnosing the disease, determining prognosis, predicting response to a targeted therapy, or monitoring response to therapy. Testing quality, including accuracy and timeliness, is imperative for correct disease prognosis and identification of patients who may or may not benefit from a targeted therapy. Assessing current biomarker testing practices may help doctors identify gaps and variations in testing as well as on potential ?best practices? that may be informative and generalizable to community oncology programs.

Yoga Program for Improving the Quality of Life in Couples Coping With Cancer

This clinical trial seeks to learn if a yoga program can improve physical performance, quality of life and symptom burden in cancer patients who are undergoing radiation therapy, and their partners. Taking part in yoga or stretching sessions may lower distress, improve quality of life, and/or may improve sleep and fatigue for cancer patients and their caregivers.

Evaluation of Canakinumab in High-Risk Former-Smokers

This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving canakinumab may block the inflammatory system and could have positive effects to reduce cancer growth.

Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers

This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.

Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration With Suction in Obtaining Samples From Patients With Suspected Nodal Metastatic Lung Cancer

This trial studies how well endobronchial ultrasound-guided transbronchial needle-aspiration (EBUS-TBNA) with suction works in obtaining samples from patients with suspected lung cancer that has spread to the nodal. EBUS-TBNA samples obtained with additional suction may help to improve material-amounts and decrease blood contamination in the samples.

Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool

This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.

Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer

This study evaluates how useful and acceptable the components of the "Couples Coping Together Against Cancer", referred to as "The Program", are to the participants with cancer.

CONNECTing to LungCare

This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation and lung cancer screening between patients and providers. Shared decision making is a patient care model in which providers offer information regarding risks and benefits, patients express their values and preferences, and then healthcare decisions are jointly discussed between the patient and provider. Patient education, aided by decision support tools, can increase patients' knowledge, decrease their decisional conflict, promote decision making, and improve the patients' perception of risk. CONNECTing to LungCare is an interactive education intervention that addresses lung cancer screening and smoking cessation and provides participants with a tailored summary that may make them more likely to have shared decision-making discussions with their providers about smoking cessation and lung cancer screening.

Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy

This study collects information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself. This may help researchers develop methods to predict the risk of side effects for future patients and learn the long-term benefit of proton therapy.

Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial

This phase II trial studies the effects of canakinumab in preventing lung cancer in patients who have high-risk pulmonary nodules. Canakinumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving canakinumab may prevent the development of lung cancer.