UC Davis Health Clinical Studies

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

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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

A Study of the Safety and Activity of Experimental ABBV-744 For Metastatic Prostate Cancer and Acute Myeloid Leukemia

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This is a research study for an experimental drug called ABBV-744. It will be studied in patients with relapsed/refractory acute myeloid leukemia (AML). An investigational drug is one that has not been approved by the FDA. The purpose of this study is: - to see if ABBV-744 is safe - to determine a safe dose of ABBV-744 - to see how much ABBV-744 is in your blood at various times (these tests are called "pharmacokinetics" or "PK") - to determine if treatment with ABBV-744 leads to tumor shrinkage. This study is for patients with relapsed (cancer has returned) or refractory (cancer is not responding to treatment) acute myeloid leukemia. The study sponsor (AbbVie) requests that we site collect tissue samples (including blood samples and tumor biopsies) for research purposes. This can help researchers (including your doctor and AbbVie) to better understand why certain people respond differently to ABBV-744. This is called “biomarker” research. ABBV-744 is a drug called a Bromodomain and extra-terminal (BET) inhibitor. BET proteins read DNA modifications that determine which genes are active. ABBV-744 interferes with this reading. If reading such DNA modifications are needed for the survival and growth of cells in a tumor, the tumor may be slowed or stopped.

Drug study, Phase 1
Any, age 18 years or older

A Study of the Effects of Chemotherapy on Fertility in Osteosarcoma (bone cancer) Survivors

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Incredible progress has been made in curing childhood cancers over the past 20 years. With all this success has come the awareness that childhood cancer treatment may lead to complications in some patients. This study is for patients who have previously received treatement for osteosarcoma (a type of bone cancer). Some chemotherapy drugs cause fertility problems (difficulty fathering children) in male patients. We do not know if cisplatin with or without ifosfamide causes similar problems. Problems may occur later in life for patients initially treated as adolescents and young adults. We are doing this study to learn more about possible long-term effects. The main goals of this study are: • To look at potential effects on fertility in male osteosarcoma survivors treated with cisplatin with or without ifosfamide. This will be compared to male controls without a history of cancer. • To learn whether cisplatin with or without ifosfamide changes the DNA in sperm. The other goal of this study is: • To explore how a person’s genetic makeup might change the effects that treatments for osteosarcoma have on male fertility.

Procedure study
Male, age 18 to 50 years old

A Study of Experimental Radiation Therapy With or Without Apalutamide For Stage III-IV Prostate Cancer

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This research study is for patients with prostate cancer who had surgery to remove the prostate. If your PSA level (a measure of prostate cancer) shows that your cancer has returned, this study may be right for you. People who are not in a study are usually treated with radiation therapy alone. Some patients may also receive hormone suppression drugs. However, these drugs are FDA approved for more advanced prostate cancer or prostate cancer that has spread. Therefore, hormone suppression drugs are usually not given. For patients who receive the usual approach (radiation therapy alone), about 62 of 100 patients are free of cancer after 5 years. This study will compare the effects of using the experimental drug apalutamide (study drug). It will be given along with usual radiation therapy. This combination treatment will be compared to using usual radiation therapy alone. The study drug is a hormone suppression drug. The study drug is experimental and is not FDA-approved to treat prostate cancer. The addition of the study drug to usual radiation could shrink your cancer/prevent it from returning, but could also cause side effects. 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 study drug should reduce the chance of your cancer growing back compared to the usual approach.

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