Clinical Research Directory

A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma

The goal of this clinical trial is to learn whether the Ad5.F35-hGCC-PADRE vaccine is safe and can stimulate an immune response against gastrointestinal (GI) cancers in patients with pancreatic, colorectal, esophageal, gastric, or small bowel adenocarcinomas who have completed surgical resection and standard adjuvant therapy. An additional goal is to evaluate whether the vaccine may help eliminate minimal residual disease (MRD) in ctDNA-positive colon cancer patients. The main questions it aims to answer are: Is the Ad5.F35-hGCC-PADRE vaccine safe and tolerable at different dose levels? Does the vaccine induce GCC-specific T-cell immune responses in patients with GI malignancies? In ctDNA-positive colon cancer patients, can the vaccine promote ctDNA clearance as a marker of MRD elimination? The investigators will compare immune responses across different vaccine dose levels (10¹¹, 10¹², and 5 × 10¹² virus particles) to determine the optimal dose. Participants will: Receive the Ad5.F35-hGCC-PADRE vaccine by intramuscular injection. Be assigned to one of three dose levels during the dose-finding phase or receive a prespecified dose in the dose-expansion cohort. Undergo safety assessments, including monitoring for adverse events, injection-site reactions, and laboratory test abnormalities. Have blood samples collected to evaluate GCC-specific T-cell immune responses. For ctDNA-positive colon cancer patients, undergo ctDNA testing to assess clearance of minimal residual disease.

Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays

This clinical trial is being done to learn whether using the proactive, graduated dose modification algorithm for leucovorin, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) (PAGODA) algorithm to guide chemotherapy dosing for the FOLFOX regimen works to reduce unplanned treatment delays for patients with digestive system cancers compared to usual care. During standard of care treatment, chemotherapy dose changes or treatment delays are typically determined by the treating physician based on factors such as a patient's height, weight, and blood test results obtained before each treatment cycle. If certain blood counts are too low, the next cycle of chemotherapy may be delayed or adjusted. The PAGODA algorithm is a step-by-step decision-making tool designed to help health care providers determine whether chemotherapy doses should be adjusted or delayed in patients with low neutrophil or platelet counts. Researchers will compare treatment delays, dose changes, and safety outcomes between patients managed using the PAGODA algorithm and patients receiving usual care.

Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients With Gastrointestinal, Gynecological, Breast, or Lung Cancer

This phase II trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI), gynecological (GYN), breast, or lung cancer. Fatigue poses a burden in patients with malignancies undergoing systemic chemotherapy. Fucoidan is a dietary supplement made of complex sugar that contain sulfate groups attached to their sugar units (sulfated polysaccharide) which found in brown seaweed. It is thought to have anti-inflammatory, anti-viral, anti-thrombotic, anti-diabetic, and anti-tumor effects in pre-clinical models. Giving fucoidan may be effective in preventing chemotherapy-related fatigue in patients with GI, GYN, breast, or lung cancer.

Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes

This study examines at-home monitoring of patient-generated phsyiologic health data and patient-reported outcomes. Patient-generated health data using at-home monitoring devices and smart device applications are used more and more to measure value and quality in cancer care. This trial may show whether at-home monitoring programs can improve the care of patients after hospital discharge from surgery.

Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord

This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.

Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study

This study evaluates the use of extended venous thromboembolism prophylaxis (ePPx) following abdominopelvic cancer surgery within the NCI Community Oncology Research Program (NCORP) network, targeting surgeons and surgical advanced practice providers (APPs).

Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies

This clinical trial studies massage therapy in reducing chemotherapy-induced nerve problems (peripheral neuropathy) that may cause pain, numbness, tingling, swelling, or muscle weakness in different parts of the body in patients with gastrointestinal or breast malignancies. Massage therapy may help reduce chemotherapy-induced peripheral neuropathy symptoms and improve quality of life.

Studying the Workflow of the American College of Surgeons Geriatric Surgery Program to Improve Clinical Outcomes in Older Adults Undergoing Surgery at the James Cancer Hospital

This study examines how the American College of Surgeons Geriatric Surgery Verification Program, also called the ACS GSV Program, is implemented at the James Cancer Hospital. The program is designed to improve surgical care for adults age 65 and older by helping care teams identify and address age-related needs before, during, and after surgery. Older adults with cancer may have concerns related to physical function, memory or thinking, medications, social support, and goals of care. If these needs are not recognized, patients may be at higher risk for complications, longer hospital stays, readmission, or discharge to a facility instead of home. The ACS GSV Program includes standards for geriatric surgery leadership, goals-of-care discussions, screening for age-related vulnerabilities, care plans for identified needs, age-friendly perioperative care, and regular review of surgical outcomes. This study will evaluate how well these standards are adopted across surgical oncology services and whether implementation is associated with better outcomes, such as shorter hospital stays, fewer complications, fewer readmissions, and improved discharge outcomes. The results may help improve surgical care workflows for older adults undergoing cancer surgery.

Evaluation of Portal Vein Stenting in Patients With Portal Vein Stenosis and Gastrointestinal Cancers

This study collects information about the safety and effect of portal vein stenting in gastrointestinal cancer patients with portal vein stenosis. This study may help researchers learn how long the portal vein stays open and free from blockage and the effects of portal vein stenting on patients' overall well-being.

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.

Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy

This phase I/II trial compares the effect of drugs that causes widening of blood vessels as a result of smooth muscle relaxation (vasodilator therapy) with isosorbide mononitrate, diltiazem or placebo to reduce vasotoxicity in patients with gastrointestinal cancer receiving fluoropyrimidine therapy. Some patients develop chest pain (possibly even a heart attack, a drop in heart function, or a rhythm abnormality) during treatment with a class of cancer drugs known as fluoropyrimidines, which include 5-Fluorouracil (5-FU) and capecitabine. These side effects are believed to be due to the development of an abnormal reactivity of the blood vessels referred to as vasospasm. Vasotoxicity is damage or toxicity inflicted upon blood vessels (vascular system), often causing dysfunction, remodeling, or narrowing (vasoconstriction). It is a broad term used to describe the detrimental effects of certain agents, such as chemotherapy drugs. Researchers want to evaluate how often the reactivity of blood vessels becomes abnormal, during the treatment with 5-FU or capecitabine and how clinically relevant and controllable/preventable this phenomenon is in patients with gastrointestinal cancer.

Molecular Epidemiology of Biliary Tree Cancers

This study is to learn if certain risk factors (environmental, viral, behavioral, medical, and dietary), tumor markers, and genetic changes can predict the development and outcome of biliary tree cancers. Establishing biomarkers models from patients may help doctors to further understand how biliary tree cancer is affected by different treatments, and why some people's cancer responds differently than others.

Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

This study aims to see whether an at-home monitoring program that collects health, symptoms, and quality of life data in real-time can be included as part of the care of surgery patients in order to provide better recovery. Patient-generated health data (weight, temperature, oxygen level, heart rate, blood pressure, daily steps, symptoms, quality of life) using at-home monitoring devices (thermometer, a pulse oximeter, a digital scale and a Vivofit 4 watch) and smart device applications are used more and more to measure value and quality in cancer care. However, measuring patient-generated health data is not currently part of standard care following cancer surgery. An at-home monitoring program may improve the care of patients after hospital discharge from surgery and may help reduce complications by identifying issues early.

2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers

This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 hours) may prevent or delay the development of nerve damage, which may keep patients on standard doses of chemotherapy longer, without having to delay treatment.