This is a study for subjects with transitional cell carcinoma. Transitional cell carcinoma (TCC) is a type of cancer that is usually from the bladder, but can also be from organs associated with the bladder, such as the ureters (tubes connecting the bladder with the kidneys). This research study is evaluating a drug called Everolimus, also known as RAD001, which will be used either alone or with another drug called Paclitaxel as a possible treatment for TCC. Patients with this type of cancer routinely receive Cisplatin-based cancer treatment. However, the study doctor may think that this routine Cisplatin-based cancer treatment will not be good for the patient due to the disease or health condition. After discussing with the study doctor, the patient has the option of participating in this study to receive either Everolimus alone (cohort1) or Everolimus in combination with Paclitaxel (cohort2).
If the patient chooses to take part in cohort 1 of this study, the patient will take Everolimus 10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis. The patient will be provided with an adequate supply of Everolimus for self-administration at home.
If the patient chooses to take part in cohort 2 of this study, the patient will receive Everolimus 10 mg daily orally, as described above, along with Paclitaxel 80mg/m2 given intravenously (in your veins), over one hour on days 1,8 and 15 of a 28-day cycle
The study team would like to keep track of the patient's medical condition for the rest of their life. The study team would like to do this by calling the patient on the telephone once every few months (every 3 months for 2 years from registration for protocol therapy, every 6 months for years 3 - 5 and annually thereafter) to see how the patient is doing. Keeping in touch with the patient and checking the condition helps the study team look at the long-term effects of the research study.
This study is for subjects with metastatic renal cell cancer (kidney cancer that has spread to other parts of the body) that cannot be cured or easily controlled. The purpose of this study is to assess how subjects feel during treatment with each of the drugs and to see which drug they prefer at the end of the study. A second goal of this study is to compare the safety and side effects of tivozanib and sunitinib. A third goal of the study is to see how well tivozanib and sunitinib slow the growth of or shrink tumor(s).
Tivozanib and sunitinib are anti-angiogenesis medicines that fight cancer by cutting off a tumor’s blood supply, so that it does not get the blood and nutrients it needs to grow. This study will compare treatment with tivozanib and sunitinib, also referred to as the “study drugs”. Tivozanib is an investigational drug that has not been approved for sale in any country; however, previous clinical trials using tivozanib as treatment revealed that the drug shrank kidney cancers and slowed the growth of these tumors. Sunitinib is a standard treatment for those with advanced renal cell cancer, and has been approved for sale by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and several other government agencies.
Subjects will be treated with each study drug, one after the other. They will receive either tivozanib or sunitinib for 12 weeks and then will switch to the other drug for 12 weeks. They will be randomly assigned to receive either tivozanib or sunitinib for the first 12 weeks, meaning the drug they receive first will be decided by chance (like the flip of a coin). It is expected that subjects will take the same dose of tivozanib for the entire 12 weeks and the same dose of sunitinib for the entire 12 weeks during the study. Participation in this study may last up to approximately 33 weeks.
The main purpose of this study is to evaluate CNDO-109 Activated Allogeneic Natural Killer Cells (NK Cells) and how participants with Acute Myeloid Leukemia (AML) respond when given this therapy. The primary objective of this study is to define the maximum tolerated dose (MTD), or the maximum tested dose of CNDO-109-Activated Allogeneic Natural Killer cells infused (given) after preparative chemotherapy. NK cells are a type of blood cell in your immune system that attack cancer cells.
Subjects enrolled in this clinical trial have advanced soft tissue sarcoma that their doctor plans to treat with doxorubicin (a chemotherapy drug). Researchers want to find out if an investigational drug called TH-302 can help patients with advanced soft tissue sarcoma when it is combined with doxorubicin.
The purpose of this study is to gather information on the safety and effect on this cancer of TH-302 in combination with doxorubicin. The study will also look at how the drug is processed in the body. Participants will undergo a screening process to determine if he or she is eligible to participate in the study. If a subject is eligible and chooses to participate, he or she may receive treatment for approximately 6 months or 23 weeks. The treatment period is divided into 3-week periods called “cycles.” Subjects will be randomly assigned (like flipping a coin) to one of the following treatment arms:
A)TH-302 plus doxorubicin: TH-302 once a week for 2 weeks followed by one week off. Subjects will receive doxorubicin on the first day of each 3-week cycle.
B) Doxorubicin alone: Doxorubicin only on the first day of the 3-week cycle.
Subjects may receive up to 6 cycles of treatment. A end of study visit will be completed once the subject stops study treatment.
The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied. Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die. Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
If the participants are found to be eligible to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If they are in Group 1, they will take bevacizumab.If the participants are in Group 2, they will take vacizumab and vorinostat
The participant may take the study drug(s) for up to 1 year. Participation on this study will end once the participant completes the end-of-dosing visit and long-term follow-up.
The primary objective of this study is to evaluate overall survival between patients randomized to receive post-operative ipilimumab versus those randomized to receive high-dose interferon.
Secondary objectives are to:
- Compare disease recurrence-free survival in the two groups;
- Evaluate safety and tolerability of post-operative ipilimumab therapy; and
- Compare the quality of life between the two groups.
This study will help to understand the roles of the immune system in controlling colon cancer. It may advance science, leading to future development of an effective treatment of colon cancer.
The purpose of this study is to see if adding the oral chemotherapy pill, sorafenib (Nexavar), to localized chemotherapy (chemoembolization) to the liver will help patients to live longer than treatment with localized chemotherapy to the liver without sorafenib. Sorafenib is currently approved by the United States Food and Drug Administration for the treatment of liver cancer. It is not known if the combination of chemoembolization and sorafenib will work better than chemoembolization alone.
The part of this study considered “investigational” is the addition of sorafenib to chemoembolization for the treatment of unresectable hepatocellular carcinoma (HCC).
The purpose of this study is to find out if treatment with ruxolitinib helps relieve symptoms associated with (Polycythemia Vera )PV compared to hydroxyurea. Ruxolitinib is a medicine which has been approved by the United States Food and Drug Administration for certain patients with a disease called myelofibrosis. It is not approved for patients with PV.
If a subject joins the study you will be asked to come to the Study Doctor’s office/clinic/study site several times during the course of the study. The study is comprised of 5 phases: a Screening Phase to determine eligibility in the study; a Baseline Phase; a Blinded Treatment Phase, an Open-label Treatment Phase, an optional Extended Treatment period and a Follow-Up Phase. In certain situations, the screening and baseline visit can be combined. The Blinded Treatment Phase is expected to last at least 16 weeks, and the Open-label Treatment Phase is expected to last until all enrolled participants on the study have finished 48 weeks on the study.