UC Davis Health Clinical Studies

Experimental Combination of Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel For Advanced Biliary Tract Cancers

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

Biliary cancer is a form of cancer that develops in the bile duct system. This system connects the liver, gallbladder, and small intestine. The biliary ducts move bile, a fluid that helps digest fats, to the small intestine. The purpose of this study is to compare the effects of an experimental combination treatment. I twill be used to treat newly Diagnosed, Advanced Biliary Tract Cancers. The drug nab-paclitaxel will be added to standard treatment with the drugs cisplatin and gemcitabine. This treatment will be compared to treatment with cisplatin and gemcitabine alone. Nabpaclitaxel is an FDA-approved drug for other diseases. It is experimental in this study. The addition of the study drug nab-paclitaxel could shrink your cancer. It could also cause side effects. This study will help the study team learn whether this different approach is better, the same, or worse than standard treatment. In this study, you will get either: - cisplatin and gemcitabine, or - nab-paclitaxel with cisplatin and gemcitabine.

Drug study, Phase 3
Any, age 18 years or older

Experimental Study of a New Drug Combination - Copanlisib and Fulvestrant - in Postmenopausal Women With Advanced Breast Cancer

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

The purpose of this study is to compare any good and bad effects of using a specific drug, copanlisib. It will be given along with standard therapy with fulvestrant for advanced breast cancer. The addition of copanlisib to the usual therapy of fulvestrant alone could shrink your cancer/prevent it from returning. It could also cause side effects. The genetic make up of your breast cancer will be important to know before you start treatment in the trial. If you have a protein called PI3K or PTEN, copanlisib may work better when given with fulvestrant to block cancer cell growth. PI3K and PTEN are often altered (or mutated) in cancer cells. If you do not have PI3K or PTEN alterations in your tumor you may still benefit from this therapy. Researchers hope to learn if tumor genetic information is important in predicting if your cancer will respond to fulvestrant and copanlisib. This study will allow researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the addition of copanlisib should shrink breast tumors in about 1 out of every 3 patients treated on this study. Copanlisib is already FDA approved for use in follicular lymphoma. It is usually not used for the treatment of breast cancer and is considered experimental in this study.

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

Experimental Pembrolizumab Alone or Combined With Pemetrexed and Carboplatin For Advanced Non-Small Cell Lung Cancer (NSCLC)

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

This study is being done to answer the following questions: Does immunotherapy with MK-3475 (pembrolizumab) alone improve overall survival? This will be compared to combination therapy with chemotherapy, in patients with your type of cancer. Does additional treatment with chemotherapy following immunotherapy alone also improve overall survival? We are doing this study because we want to compare these two usual approaches to cancer treatment. The usual approach is defined as care most people get for PD-L1 positive non-squamous non-small cell lung cancer.

Drug study, Phase 3
Any, age 18 years or older

Experimental Iobenguane I-131 or Crizotinib and Standard Therapy For Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

In this study, researchers want to find out if we can improve the treatment for subjects with high risk Neuroblastoma (NBL). We will study the addition of experimental drug I-MIBG or the experimental drug Crizotinib to standard therapy. We also want to find out if we can reduce the number of stem cell transplants from two to one. I-MIBG is an experimental anticancer drug. It has not been approved by the FDA for use in treating high-risk NBL. I-MIBG has been used to treat NBL that did not respond to therapy or NBL that has come back. I-MIBG has been shown to be well tolerated in children with cancer. I-MIBG can only be given at certain hospitals and you may need to travel to another hospital if you choose to participate in this study. Some patients in the study will receive only one stem cell transplant instead of two back-to-back stem cell transplants. Subjects who have only one stem cell transplant will get two chemotherapy drugs called busulfan and melphalan (BuMel). These are given instead of the drugs usually used for back-to-back stem cell transplants. BuMel is an accepted transplant chemotherapy regimen in Europe and other parts of the world. It is not part of current Children's Oncology Group (COG) recommended therapy. Crizotinib is an experimental anticancer drug. It has not been approved by the FDA for use in treating high-risk NBL. Crizotinib has been approved by the FDA for use in treating adults with certain types of lung cancer that has spread. Crizotinib has been well-tolerated in children and adults with cancer. Crizotinib will only be used in subjects whose tumor shows changes in a gene called ALK. Changes in the ALK gene are only found in 10-15% of children with high-risk NBL. The overall goals of this study are to: • Compare the effects, good and/or bad, of the experimental drug I-MIBG added to current COG recommended therapy. • Compare the effects, good and/or bad, of the experimental drug crizotinib added to current COG recommended therapy. Another goal of this study is to: • Evaluate the effects, good and/or bad, of using the experimental drug I-MIBG in the setting of single cell transplant with BuMel conditioning during Consolidation therapy. These effects, good and/or bad, will be studied but will not be directly compared to current COG recommended therapy.

Biological study, Phase 3
Any, age -1 to 30 years old

A Study of Experimental Accelerated vs Standard Chemotherapy for Germ Cell Tumors (formed from reproductive cells)

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

Standard treatment for advanced germ cell tumors includes three chemotherapy drugs. This is called BEP (Bleomycin, Etoposide, and cisPlatin). BEP is given with a drug called pegfilgrastim or filgrastim. This makes white blood cells grow. These drugs are given over the course of 3 weeks. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen. It will use the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. This method works by giving the dose of chemotherapy drugs over a shorter length of time. Instead of the standard 3 week-cycle, patients would receive their treatment in a 2 week-cycle. The overall goal of this study is to determine whether accelerated BEP will be effective and well-tolerated for patients with advanced GCTs. We don’t yet know if accelerated treatment is helpful in advanced GCTs and we are hoping this study will answer that question.

Drug study, Phase 3
Any, age 11 to 45 years old
Loading