UC Davis Health Clinical Studies

Experimental Vedolizumab for Acute Graft Versus Host Disease (aGVHD) in Stem Cell Transplants

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a vital therapy. It is used in patients that have various forms of blood cancer. In these patients, the risk of disease recurrence or progression is significant. In this treatment, the patient first receives chemotherapy and/or radiation therapy. This kills blood–forming cells (cells from which all blood cells develop). Then, they receive blood-forming stem cells. These are taken from a genetically similar donor. There can be a complication of graft versus-host disease (GvHD) after this procedure. GvHD occurs when some types of white blood cell (T cells) in the donated cells (the graft) attack your own body cells. This happens because the graft see your body cells (the host) as foreign and attacks them. GvHD can vary in severity depending upon how soon it occurs after transplant. Acute GvHD occurs under 100 days after an allo-HSCT, but can also occur beyond 100 days. Acute graft versus-host disease (aGvHD) most commonly involves the skin, liver or intestines. This study will follow patients for the development of intestinal aGvHD during the first 180 days after allo-HSCT. This research study will test the safety and effectiveness of experimental Vedolizumab. It will be compared to placebo (dummy drug). It is being tested for the prevention of intestinal aGvHD. It will be given to patients undergoing allo-HSCT from an unrelated donor for a hematologic malignancy. These are cancers that affect the blood and/or lymphatic system. This clinical research study will test the anti-inflammatory properties of Vedolizumab. It is given intravenously (IV) directly into your vein using a needle.

Drug study, Phase 3
Any, age 12 years or older

Study of Experimental ASTX660 For Advanced Solid Tumors and Lymphomas

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The purpose of the study is to test the safety of ASTX660 and to see if this drug has an effect on treating your cancer. The drug (ASTX660) that will be given to you in this study is investigational. This means it has not yet been approved for treatment of any disease, including cancer. There are 2 phases in this study, Phase 1 (early stage) and Phase 2 (later stage). Phase 1 has now been completed. In Phase 1, successive small groups of subjects (people who take part in research studies are referred to as "subjects") received increasing doses of the study drug (ASTX660), to find the highest dose that could be safely given to most subjects and also produce the expected effects on tumor cells. The results of the Phase 1 part of the study have led to the identification of a recommended dose to use in Phase 2, as described later in this document. The Phase 2 part of the study will evaluate the effect of the study drug in subjects with specific tumor types. This ICF applies to Phase 2.

Drug study, Phase [/1/,/ /2/]
Any, age 18 years or older

Experimental Combination of AMG 510 and Trametinib for Advanced Solid Tumors With KRAS p.G12C Mutation

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This research study will test the effects of an experimetnal combination therapy. Experimental AMG 510 will be given with trametinib. This combination is being tested to treat certain cancer types with a specific mutation called KRAS p.G12C. Experimetnal AMG 510 is an anticancer drug. It is being developed for tumors with a specific mutation called KRAS p.G12C. Trametinib is an anticancer drug that interferes with the growth and spread of cancer cells in the body. The purpose of this study is to learn about the safety and tolerability (effects good or bad) of the combination of AMG 510 and trametinib. This study will also look at what doses of AMG 510 and trametinib are safe for people to take. The study will be conducted in two parts: Part 1 called dose exploration and Part 2 called dose expansion. The purpose of Part 1 of the study is to find out whether certain dose levels of AMG 510 and trametinib are safe and tolerable. The purpose of Part 2 is to test the safety of the study drug combination and understand their effect on the tumor. AMG 510 is still experimental and is not approved by any regulatory health agency such as the FDA. You will also receive trametinib in this clinical trial. Trametinib is approved in USA to treat certain cancer types. However, it is not approved in combination with AMG 510.

Drug study, Phase 1
Any, age 18 to 100 years old

Experimental Immunotherapy (Nivolumab or Brentuximab Vedotin) With Chemotherapy for Advanced Stage Classical Hodgkin Lymphoma

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This study is being done to answer the following question: Which treatment will extend your time without disease more? - Adding the study drug nivolumab to standard chemotherapy OR - Adding the study drug brentuximab vedotin to standard chemotherapy We will also compare any side effects you may have and your well-being when you take the study drugs and for up to ten years after you stop taking these drugs to treat the cancer. The usual approach for adults who are not in a study is treatment with standard chemotherapy. These treatments have been approved by the FDA. The usual approach for children and adolescents who are not in a study is treatment with standard chemotherapy, which may be followed by radiation therapy. Chemotherapy is a name for drugs that fight cancer cells. Radiation therapy is the use of high energy x-rays to kill cancer cells. There are several chemotherapy drugs approved by the FDA that are commonly used with the radiation therapy.

Drug study, Phase 3
Any, age 12 years or older

A Study of Experimental Combination Treatment for Relapsed, Refractory or Progressive Neuroblastoma

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With the hope of finding a new therapy for fighting the type of cancer that you have, you will receive the following drugs on this study: · Irinotecan, temozolomide, dinutuximab, and sargramostim (GM-CSF) or · Irinotecan, temozolomide, dinutuximab, and sargramostim (GM-CSF) with eflornithine (DFMO) The drugs irinotecan and temozolomide have been used to treat adults and children with different types of cancer. This drug combination has also been used in patients with relapsed/refractory cancers. This includes patients with relapsed/refractory NBL. This drug combination was well tolerated. This means it did not result in too many side effects for patients. Dinutuximab works differently than most standard chemotherapy drugs. Dinutuximab is a monoclonal antibody. Monoclonal antibodies are proteins made in the lab, designed to attach to specific targets on cancer cells. When dinutuximab attaches to NBL cells, the body’s immune system is stimulated to attack and kill the NBL cells. Dinutuximab is a kind of cancer therapy called immunotherapy. Unlike chemotherapy and radiation it targets cancer cells without destroying nearby healthy cells. Dinutuximab has been given with irinotecan and temozolomide in patients with relapsed/refractory NBL. This combination was well tolerated. GM-CSF is a substance that is similar to one made by the body. Under normal circumstances, the body makes small amounts of GM-CSF. This helps it produce normal infection-fighting white blood cells. It is now possible to make GM-CSF outside of the body and give humans much higher amounts than their own bodies make. In the lab and in animals, GM-CSF increases the anti-cancer effect of monoclonal antibodies like dinutuximab. Eflornithine (DFMO) is an investigational drug that is not yet approved by the FDA for use in cancer patients. DFMO has been approved by the FDA for treatment of an infection called trypanosomiasis. DFMO blocks the production of chemicals called polyamines that are important in the growth of cancer cells. This drug has been used in adults with cancer. It has also been tested both alone and in combination with chemotherapy in children with cancer. It has been tested in children with neuroblastoma. There is some evidence that polyamines may play an important role in childhood tumors. This is especially true in tumors that depend on the abnormal activity of MYC genes (like neuroblastoma). In the laboratory, DFMO and chemotherapy are able to reduce the growth of neuroblastoma tumors. DFMO may also help the body’s immune system kill NBL cells, and may help immunotherapies like dinutuximab work better. We want to find out if giving DFMO along with dinutuximab, GM-CSF, irinotecan, and temozolomide is tolerated. We also want to see how effective the drug combination is against relapsed or refractory NBL. The overall goal of this study is to find out what effects: - DFMO given with - irinotecan, - temozolomide, and - dinutuximab has on children and young adults with relapsed or refractory NBL. In addition to the treatment goal, we would like to answer some biology research questions that might benefit future patients. We will also ask you about any pain you are having during therapy. These studies are described later in this form.

Biological study, Phase 2
Any, age 1 years or older

Experimental Combination of Dabrafenib and Trametinib After Radiation For High-Grade Glioma (brain/nervous system cancer)

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The goal of this study is to test using two experimental drugs called dabrafenib and trametinib after radiation treatment. We hope to learn if it will be better than treatments used in the past to help get rid of or shrink HGG. The treatment involves cancer fighting medicines plus radiation. The treatment on this study takes a little over 2 years. It is divided into 2 phases of therapy. All people who receive cancer treatment are at risk of having side effects. In addition to killing tumor cells, cancer therapies can damage normal tissue and produce side effects. Common side effects of cancer therapy include nausea and fatigue (tiredness). Drugs may be given to try to prevent or decrease nausea. This study uses the investigational drugs dabrafenib and trametinib.

Drug study, Phase 2
Any, age 3 to 25 years old

Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery

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This study is being done to answer the following question: - Can blood sample and testing for circulating tumor DNA (ctDNA) help determine treatment for an early stage colon cancer? We are doing this study because we want to find out if testing for ctDNA and further chemotherapy is better or worse than the usual approach for your colon cancer that has been treated with surgery. We are also doing this study to see if the ctDNA test can: - identify patients with colon cancer after surgery who do benefit from receiving chemotherapy - identify those who do not benefit from receiving chemotherapy. The usual approach is the care most people get for colon cancer that has been treated with surgery. The usual approach for patients who are not in a study is no further treatment unless their cancer returns. All patients in this study are considered to be at low-risk for cancer returning unless ctDNA is found in their blood sample. For patients with a high-risk of the cancer returning, the usual approach after surgery is chemotherapy with mFOLFOX6 or CAPOX. Chemotherapy that may be recommended as part of this study is considered to be the usual approach for patients with high-risk colon cancer. For patients who receive the usual approach for low-risk colon cancer, on average, about 90 out of 100 are free of cancer after five years.

Drug study, Phase [/2/,/ /3/]
Any, age 18 years or older

Experimental Topotecan and M6620 for Relapsed Small Cell Lung Cancer or Extrapulmonary Small Cell Cancer

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This study is being done to answer the following questions: - Can we lower the chance of your relapsed SCLC growing or spreading by using M6620 and topotecan combination therapy? - Can we lower the chance of your small cell cancer outside of the lungs growing or spreading using M6620 and topotecan combination therapy? M6620 is experimental and that it has not been approved by the FDA for this type of cancer. We are doing this study because we want to find out if a new approach is better than the usual approach for your relapsed SCLC or outside of the lungs small cell cancer. The usual approach is defined as care most people get for relapsed SCLC or for small cell cancer outside of the lungs. The new approach we are testing is a combination of topotecan and M6620. The usual approach for patients with relapsed small cell lung cancer who are not in a study is treatment with topotecan. Topotecan is one of the FDA-approved treatments for patients with relapsed SCLC. The usual approach for patients with small cell cancer outside of the lungs follows the patterns of treatment for SCLC. There are no FDA approved drugs for small cell cancers outside of the lungs.

Drug study, Phase 2
Any, age 18 years or older

Experimental Niraparib With Radiation Therapy and Androgen Deprivation Therapy for High Risk Prostate Cancer

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This study is being done to answer the following question: Can we lower the chance of prostate cancer growing or returning by adding a new experimental drug to the usual treatment? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer that has a high chance of coming back. The purpose of this part of the study is to determine the ideal dose of the study drug. You are being asked to take part in the initial dose-finding part of this study (phase I). The purpose of this part of the study is to test the safety of the study drug niraparib added to usual treatment for your type of prostate cancer. The study drug is not approved by the FDA for use in patients with prostate cancer. We will test the safety of adding the study drug by looking at the side effects experienced by patients in this part of the study. If adding the study drug to usual treatment is safe, a second portion of the study (phase II) will open to additional patients. Phase II will compare any good and bad effects of the study treatment to the usual therapy. Researchers will use some of the information obtained from the patients in the dose-finding portion to find this out.

Biological study, Phase 2
Male, age 18 years or older

Radiation Therapy With or Without Experimental Trastuzumab For Women With Ductal Carcinoma After Lumpectomy

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This study will test radiation therapy to see how well it works with or without experimental trastuzumab. It will be give to women with ductal carcinoma who have undergone lumpectomy (surgery to remove breast lump). Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. They can also carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma.

Other study, Phase 3
Female, age 18 years or older
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