Clinical Trials Search at Vanderbilt-Ingram Cancer Center

This early phase I trial studies how well ketogenic diet with letrozole works in treating patients with estrogen receptor positive breast cancer. Estrogen receptor positive breast cancer has special proteins on it, called estrogen receptors, that allow it to grow when exposed to estrogen. A ketogenic diet (low calorie, low carbohydrate) may help normalize abnormally high insulin levels that in turn may slow the growth of cancer cells. Letrozole may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this study is to learn if the combination of a 2 week ketogenic diet in combination with letrozole can help slow the growth of tumors.

This phase II trial tests how well itacitinib works in in patients with immune related adverse events (irAEs) arising from immune checkpoint inhibitors (ICI) that do not respond to steroids (steroid refractory). Steroids are the usual treatment for these side effects. However, sometimes steroids do not improve or fix the side effects. Giving itacitinib may be effective in treating patients with known or suspected problems coming from ICIs, that do not resolve or improve with steroids, by reducing the patients immune system response that can cause the irAEs.

This is a Phase II, single arm, multi-center trial, designed to estimate the efficacy and
toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell
disease (SCD). Based on their age and entry criteria patients are stratified into two groups:
(1) children with severe SCD; and (2) adults with severe SCD.

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent
chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the
study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy
regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the
recommended dose determined in Part 1.

High-dose chemotherapy followed by blood stem cell transplantation is administered to
lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously
causes damage to healthy tissues that frequently result in severe complications that lead to
hospitalization and can be life threatening. These severe complications involve the blood,
immune, gastro-intestinal systems, and other vital organs.

The purpose of this study is to determine if experimental therapy AB-205 (study drug) can
prevent or reduce the occurrence and duration of the severe chemotherapy related
complications when compared to placebo in patients with lymphoma undergoing treatment with
high-dose chemotherapy and blood stem cell transplantation. All patients, whether treated
with AB-205 or placebo, will receive standard preventive and supportive care therapies.

This trial studies the impact of indwelling tunneled pleural drainage systems (gravity or vacuum based) on pain in patients with plural effusion that has come back (recurrent). Vacuum drainage and gravity drainage are two commonly used drainage methods. Studying the best drainage methods may help future patients undergoing indwelling tunneled pleural catheter placement.

This phase II trial tests whether PEA works to relieve the symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer. Chemotherapy-induced peripheral neuropathy refers to a nerve problem that causes pain, numbness, tingling, or muscle weakness in different parts of the body, and is caused by chemotherapy. PEA may be useful against bothersome nerve symptoms.

This clinical trial evaluates the clinical effectiveness of a multi-level telehealth-based intervention for cancer patients in rural communities. Rural residents face limited accessibility to cancer treatment and supportive care services, transportation barriers, and financial issues. Cancer Thriving and Surviving is an evidence-based self-management intervention with demonstrated efficacy across numerous chronic health conditions with dissemination across the US, inclusive of rural communities. This trial evaluates whether the evidence-based Cancer Thriving and Surviving intervention delivered through telehealth among rural patients may improve patient outcomes.

This phase II trial studies the treatment response for patients with acute graft-versus-host disease (GVHD). GVHD occurs when donor immune cells attack the healthy tissue of a bone marrow or stem cell transplant patient. The standard treatment for GVHD is to lower the activity of the donor cells by using steroid medications such as prednisone. But steroid treatment may cause many complications and the risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses. Researchers are doing this study to find out how many subjects respond well to lower steroid dosing based on a blood test (GVHD biomarker) and if they develop fewer complications.

This clinical trial tests virtual reality (VR) in the management of pain, stress, and feelings or emotions (affect) in patients undergoing treatment for cancer in infusion clinics. Patients receiving treatment in infusion clinics are often sitting in a single location for an extended period of time which can lead to high levels of anxiety, pain, and depression. VR technology can create and immersive, computer-generated experience that a patient can interact with and navigate through. Because of the immersive nature of VR, this therapeutic technology could positively impact pain, stress, and/or affect of cancer patients undergoing treatment.