The purpose of this study is to test how well the experimental drug dolutegravir (DTG) works in treating HIV when given after raltegravir or elvitegravir have stopped working. Dolutegravir is a new drug to treat HIV which works the same way as the other integrase inhibitors and has been shown to be effective in some people for whom raltegravir or elvitegravir are no longer effective.
The study has 2 phases:
Participants will continue taking dolutegravir plus the medication chosen by the physician for up to 48 weeks, and possibly longer if the treatment is beneficial for the participant.
For the convenience of our study participants, we have 2 locations:
Upper East Side/East 68th Street: Baker 24 at NewYork-Presbyterian/Weill Cornell Medical Center
Men who have sex with men (MSM) have an increased risk of developing anal human papillomavirus (HPV) infections. Anal HPV infection can be a risk factor for anal cancer, which is a common non-AIDS-defining cancer among HIV-infected MSM. Screening for anal cancer is not widely available and can be difficult to implement. People who receive the FDA-approved quadrivalent HPV vaccine, Gardasil, may have a reduced risk of developing anal HPV infection, which may in turn reduce the risk of developing anal cancer.
The purpose of this research study is to determine if Gardasil prevents anal HPV infection in HIV-positive men age 27 and older.
Gardasil has been approved by the FDA for prevention of HPV infection in males and females age 9-26. The vaccine has not been approved for use in men over the age of 26. Gardasil is called a “quadrivalent vaccine” because it is directed at four types of HPV that are sexually transmitted and associated with genital warts and cancer risk.
At a baseline study visit, participants will undergo a physical examination, blood collection, anal swab procedure, oral examination and saliva collection, and questionnaires.
Study participants will be randomly assigned to receive either the HPV vaccine or a placebo. The placebo is made like the vaccine but does not contain the HPV ingredient. Neither you nor the study staff will know whether you received vaccine or placebo until the study is over. Participants will be injected with the vaccine or placebo at study entry, Week 8 and Week 24. Participants will then be seen for follow-up twice a year for 2 to 3 years.
Participants will undergo:
You will be compensated for your time at each study visit.
For the convenience of our study participants, we have 2 locations:
Upper East Side/East 68th Street: Baker 24 at NewYork-Presbyterian/Weill Cornell Medical Center
The purpose of the study is to determine the effectiveness of treating people with ET and PV with aspirin and Pegylated Interferon Alfa-2a instead of the standard treatment hydrooxyurea, because the standard treatment may not be suitable for them.
Pegylated Interferon Alfa-2a is a type of interferon, which is a form of a hormone produced naturally in the blod which reduces the production of blood cells. It has been shown to reduce the amount of a protein thought to be involved in causeing ET and PV. Pegylated Interferon Alfa-2a will be given by a subcutaneous injection every week.
]]>The purpose of the study is to determine which treatment-- experimental drug called INC424 or the best available therapy--is better for treating PV. The study will also determine if INC424 is safe and has beneficial effects in people who have polycythemia vera.
Blood cells are made in the bone marrow. An enzyme called JAK2 sends signals telling the bone marrow to produce more blood cells when they are needed. But in most people who have polycythaemia vera, the JAK2 enzyme is faulty and this makes the bone marrow produce too many red blood cells. INC424 blocks the action of the JAK2 enzyme and may reduce the number of red blood cells.
Study participants will be randomly assigned to receive either INC424 or the best available therapy. If selected for best available therapy, participants and the study doctor will choose the treatment that best fits their condition.
Participants receiving INC424 will take 2 tablets daily for up to 80 weeks.
]]>This clinical trial is for people diagnosed with Primary Myelofibrosis, Post Essential Thrombocythemia-Myelofibrosis, and Post Polycythemia Vera-Myelofibrosis whose platelet count is between 50 and 100 x109/L.
The purpose of the study is to determine the effects of treatment with the experimental drug ruxolitinib on spleen volume. The study will help determine the appropriate dosing for people with low platelets.
Study participants will receive for 24 weeks. If you are receiving benefit from treatment, further participation may continue.
]]>Acute Myeloid Leukemia is a very difficult disease to treat, especially in those who are older than 60. Standard treatment--a combination of chemotherapy drugs-is intensive and not feasible for many older patients with the disease. Also, AML in older patients is less likely to be successfully treated with chemotherapy even for those patients who can tolerate the treatment. This research study is being conducted to determine how safe and effective the combination of decitabine and plerixafor is in treating AML.
The hypothesis of this study is that combining plerixafor, an inhibitor of stromal cell derived factor, with decitabine, a DNA methyltransferase inhibitor, as induction and postremission therapy for older patients with AML will improve treatment outcomes via mobilization of leukemia stem cells and alteration of the pharmacodynamics of decitabine.
Decitabine has been shown to be an effective treatment option for some older patients with AML. Plerixafor is used to mobilize stem cells for lymphoma and multiple myeloma patients who are having a stem cell transplant. The researchers believe plerixafor may be able to mobilize leukemia cells from their hiding places inside the bone marrow and make them more accessible to decitabine treatment.
]]>This is a two-part study. The study physician will tell you which part and dose group you will be participating in prior to enrollment.
PLX3397 selectively targets a number of cell types,that are involved in various aspects of tumor growth and metastasis.
]]>This is a two-part study. The study physician will tell you which part and dose group you will be participating in prior to enrollment.
Ofatumumab is an antibody therapy that is targeted to attack the abnormal cancer cells that make up follicular lymphoma by recognizing a protein on the surface of these cells. Ofatumumab is an effective treatment for follicular lymphoma and chronic lymphocytic leukemia that comes back after people first respond to other chemotherapy. It is not known how well ofatumumab will work in patients with follicular lymphoma who have not been previously treated.
All patients in the study will receive ofatumumab. You will be randomly assigned to receive one of two doses of ofatumumab; neither you nor the study physician can choose which dose you receive. You will receive either 500 mg or 1000 mg of the study drug via infusion on days 1, 8, 15 and 22 during the first 4 weeks of treatment (induction therapy). Following induction therapy ofatumumab will be given every other month to cover a total of 9 months. During this time you will continue to receive the same dose, either 500 mg or 1000 mg, that you were initially assigned.
We expect patients to be receiving treatment in the study for approximately 9 months. After completing study treatment you will be asked to return for follow-up tests 11, 15, 19, 23, 27, 31, and 35 months after entering the study, and then every 6 months for a maximum of 10 years from study entry, unless your disease should return.
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]]>Although new anti-myeloma therapies have been developed, patients are still not cured of their disease. In a previous research study conducted at Weill Cornell Medical College, newly diagnosed multiple myeloma patients responded well to the BiRD regimen.
The new investigational drug called carfilzomib is a proteasome inhibitor. Proteasomes are found inside all cells. Blocking the action of proteasomes causes cells to die, and cancer cells are more susceptible to this effect than normal cells. The investigators hope that giving carfilzomib and dexamethasone before BIRD will lead to improvement in myeloma reduction.
Treatment Plan:
All patients will begin treatment with Carfilzomib + Dexamethasone. Carfilzomib will be given intravenous at a dose of 45mg/m2 on days 1, 2, 8, 9, 15, 16 for each 28-day cycle. Dexamethasone (Decadron®) will be given orally at a dose of 20 mg on days 1, 2, 8, 9, 15, 16, 22 and 23 for each 28-day cycle.
At the maximum disease response on Carfilzomib + Dexamethasone treatment, patients will then transition to BiRD therapy. BiRD is: Clarithromycin (Biaxin®) orally at a dose of 500 mg twice a day, Dexamethasone (Decadron®) orally at a dose of 40 mg on days 1, 8, 15 and 22, and Lenalidomide (Revlimid®) orally at a dose of 25 mg/day days 1-21 out of a 28-day cycle.
At the maximum disease response on BiRD, patients may then choose either to proceed to autologous stem cell transplant or Lenalidomide (Revlimid®) which will be given as a maintenance medication at a dose of 10 mg/day days 1-21 out of a 28-day cycle. Patients can continue on Lenalidomide maintenance for a maximum of 24 cycles (approximately 2 years).
If there is progression of myeloma at any time, the study medications will end and alternative treatment will be offered.
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Website: http://myelomacenter.org
]]>This is a clinical trial for patients with acute myeloid leukemia (AML) that possesses an abnormal molecular feature (a gene mutation). The purpose of this study is to test the safety and effectiveness of adding the drug dasatinib to a treatment regimen in patients with AML and to determine how well the leukemia responds to the treatment. The study is being done because currently available treatment is not effective in curing patients with this type of leukemia.
There are three parts to the treatment in this study. The first part of the therapy will test the safety and effectiveness of adding dasatinib to the standard combination of chemotherapy drugs used to treat AML that include daunorubicin and cytarabine. The second part of the therapy will test the safety and effectiveness of combining dasatinib with another chemotherapy treatment, consolidation therapy with high-dose cytarabine. Finally, the third part of the therapy will test the effectiveness of the use of dasatinib alone for 12 months during continuation therapy.
Patients will receive therapy for about 18 months on study. After you are finished with the therapy, you will be asked to visit the office for follow-up at least every 2 months for 2 years, then every 3 months for 2 years, then yearly for a maximum of 10 years from when you entered the study.
]]>The purpose of this study is to find out how diet may prevent prostate cancer from getting worse. Eating a diet high in vegetables may slow down disease progression in men with prostate cancer. The study will determine if a telephone-based dietary intervention, compared to no intervention, will decrease disease progression.
In the first 2 weeks after you join the study, researchers will call you on the telephone on 3 different days to ask questions about your medical history and diet. During these interviews, you will be asked to recall everything you ate and drank during the previous 24 hours. These phone interviews will take about 20 minutes.
After completing the 3 initial telephone interviews, study participants will be randomly assigned to one of two study groups:
Study participants in both groups will complete the following tests and procedures:
Participants will be in the study for 2 years.
]]>This study is being done to compare the safety and efficacy of BMS-790052 versus telaprevir, both in combination with pegylated interferon (pegIFN) and ribavirin, in subjects with chronic hepatitis C who have never been treated before. BMS-790052 is not yet approved for use by the FDA, so it can only be used in research studies such as this one. Telaprevir is approved by the FDA to treat adults with genotype 1 chronic hepatitis C when it is used in combination with pegIFN and ribavirin. It is being marketed as Incivek™.
Participation in this study may last up to 72 weeks, about a year and a half. Participation consists of a screening period, a study drug administration period of up to 48 weeks, and a follow-up period of up to 48 weeks. Subjects will be asked to visit the clinic about 20 times over the course of the study. Subjects will receive either telaprevir with pegIFN and ribavirin or the experimental drug, BMS-790052, with pegIFN and ribavirin. Subjects’ health and safety will be closely monitored during the study through physical exams, clinical laboratory tests, and reporting of side effects.
]]>First, the medication of screened individuals will be adjusted; those in whom the systolic pressure remains above 160 will then be eligible to enter the formal study.
Under this research study, eligible subjects will be randomized, with 2/3 receiving the renal denervation procedure (real procedure) along with anti-hypertensive medications while 1/3 will receive anti-hypertensive medications alone (sham procedure). All subjects will continue their anti-hypertensive medications and will be followed for the next 6 months, after which they will be informed as to whether they had had the real or sham procedure. Subjects who had received the sham procedure (medication only group) will then have the option to receive the renal denervation as well. All subjects will then be followed for an additional 30 months.
Follow-up visits will occur 1, 3, and 6 months after the procedure, then every 6 months until study completion. Follow-up visits will include a physical exam with blood pressure measurements, blood, and urine collection.
Worldwide, approximately 530 subjects will be enrolled at 60 sites.
]]>MLN8237 is available as a tablet. Patients will take MLN8237 on Days 1-7, twice a day with 8 ounces of water. Patients will continue with this treatment every 3 weeks for up to a year as long as their disease does not get worse. Whether patients remain on study treatment or not, the study physician will follow their health status for a maximum of 2 years from study enrollment.
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