28 Clinical Trials for Various Conditions
The purpose of this study is to identify novel biomarkers of kidney injury in patients receiving cisplatin. This study will also collect DNA for future analysis.
RATIONALE: Gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment. PURPOSE: This research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.
Sirolimus can be safely switched as early as 90 days after liver transplantation with excellent tolerability and amelioration of the calcineurin inhibitor toxicity that initiated the switch.
This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing 1) the safety of moxetumomab pasudotox-tdfk in patients who are 65 years of age and older and/or 2) the safety of moxetumomab pasudotox-tdfk in patients who have moderate renal impairment defined as an estimated GFR of 30-59 ml/min
This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2017.
RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia. PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.
This study will examine the following: 1) how common albuminuria and proteinuria are among HIV-positive patients, 2) what causes albuminuria or proteinuria in these patients and 3) whether the condition becomes more severe over time. HIV-infected people are more likely than others to develop kidney disease. The earliest indicator of the possible presence of kidney disease is albuminuria (increased amounts of the protein albumin in the urine). A later indicator is the appearance of other proteins, a condition called proteinuria. HIV-infected patients 8 years of age and older who do not have diabetes, chronic kidney disease or cancer may be eligible for this study. Participants provide a urine sample during three visits as follows: the first upon enrollment in the study, a second 3 months later, and a third about 6 months after that. Blood samples are drawn at the first and last visits. At the first visit a medical history is taken and blood pressure, height, weight, waist circumference, hip circumference and upper arm skin thickness are measured. Participants who are found to have albuminuria or proteinuria are asked to undergo a kidney biopsy for research purposes. The procedure is optional. Participants who develop heavy proteinuria may be recommended to undergo a kidney biopsy in order to determine the nature of the kidney disease and begin treatment. The biopsy requires a 2-day hospital stay. For the procedure, an anesthetic is given to numb the skin and a needle is inserted and guided into the kidney to withdraw a small tissue sample. The needle is passed twice, and possibly three times. Following the procedure, the subject remains in bed rest for at least 10 hours to minimize the risk of excessive bleeding.
The purpose of this study is to find substances in the blood and urine that indicate that a person has kidney damage. It will identify proteins found only in patients with acute kidney failure but not in normal healthy people or in patients with volume depletion. Adults and children who are at least 3 years old who fall into one of the following four categories may be eligible for this study: 1. Are healthy and have normal kidney function 2. Have volume depletion (this condition differs from acute kidney failure in that it is easily treated with fluids) 3. Are at high risk of kidney failure 4. Have acute kidney failure (kidney shutdown) All study participants will have a history and physical examination. Up to four blood samples of 3 tablespoons each will be taken for laboratory analysis. Urine will be collected for analysis and to measure urine output. The participants length of stay in the study varies. People with normal kidney function will be in the study for 1 day and patients with volume depletion will be studied 3 days. The length of hospitalization of patients at high risk of kidney failure or in acute kidney failure will depend on the patient s condition and medication requirements. The results of this study may lead to the development of earlier and more accurate methods for diagnosing acute kidney failure. With earlier detection, treatment could be started earlier, possibly preventing further damage and helping recovery of injury that has already occurred. ...
Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. However, due to the effects of MPA on the gastrointestinal tract, patients often complain of GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to an alternative agent, typically Azathioprine. Both of these strategies have limitations, largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse effects, so the investigators will convert patients to EVR in this study. Patients who are within their first year post-transplant will be converted to EVR upon enrollment in the study, and serial measurements ,or a series of measurements looking for an increase or decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur. For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion, as it provides an alternative to renal clearance as a route of elimination.
To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.
The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine. Researchers also want to learn how internal organs might move during radiation treatment. The goal of the second part of this study is to learn if it is safe to allow slightly more radiation to the normal esophagus when spinal tumors close by are being treated. This may result in better tumor control.
Background: * Aldesleukin (IL-2) is a drug that can help to shrink tumors in some patients with metastatic renal cancer and metastatic melanoma. It is possible that removing certain white blood cells (known as CD4 cells) before IL-2 treatment may improve the treatment effects. * Zanolimumab is an antibody that works by destroying CD4 cells in the blood. Researchers are interested in determining whether zanolimumab can improve the results of IL-2 treatment if it is given before, during, and after IL-2 treatment. In addition, further research with zanolimumab may provide more information on how IL-2 treatment causes tumors to stop growing or shrink. Objectives: - To evaluate the effectiveness of IL-2 treatment in conjunction with zanolimumab in individuals with metastatic cancer. Eligibility: - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma or metastatic kidney cancer. Design: * Eligible participants will be screened with a full physical examination and medical history, imaging studies, and blood samples, including leukapheresis, to remove a sample of white blood cells for testing purposes. Participants may also have a colonoscopy and biopsies if they have received previous treatments that have been known to cause colon damage. * Participants will be treated with zanolimumab and IL-2 treatment for 9 weeks. * Zanolimumab will be given on an outpatient basis during weeks 1 through 4, 6, 8, and 9. In weeks 5 and 7, participants will receive zanolimumab as an inpatient in addition to IL-2 therapy. * Inpatient IL-2 treatment will be given during weeks 5 and 7. Up to 15 doses of IL-2 treatment will be given over a maximum of 5 days, followed by inpatient recovery time. * During week 5, participants will have tumor imaging studies prior to receiving zanolimumab and IL-2 treatment. * About 2 weeks after the treatment period, participants will return to the clinical center for a 2-day evaluation with a physical examination, imaging studies, and blood samples. * Participants whose tumors have responded to treatment will be offered up to two additional courses of treatment, starting 6 to 8 weeks after the last IL-2 dose. Subsequent courses will be given exactly as described above in the initial course of treatment. Participants whose tumors do not respond to treatment will have follow-up evaluations as required by the study researchers.
Background: * An experimental cancer treatment procedure involves taking a patient s own tumor or blood cells, modifying them with a gene that targets proteins on the surface of tumor cells, and growing those cells in a laboratory. The modified cells are then given back to the patient by intravenous (IV) transfusion, in the hope that the new cells will attack and destroy the cancer cells without harming healthy tissue. * This procedure has been used for melanoma patients, and researchers are now attempting to use this treatment for patients with renal (kidney) cancer. In the laboratory, this attack kills nearly all kidney cancers tested, but not normal tissues. However, the effectiveness and possible side effects of this treatment are still being studied. Objectives: * To find out if cells modified to target DR4 and TRAIL (two proteins found on the surface of many kidney tumors) are effective in treating kidney cancer. * To determine the maximum tolerated dose (the highest dose that does not cause unacceptable side effects) of the modified cells. Eligibility: * Patients 18 years of age and older with metastatic renal cancer whose disease has not responded to standard treatment. * Patients will be divided into two study branches: Arm A for those who will be receiving modified cells from their biopsied tumor, and Arm B for those who will be receiving their own modified white blood cells. Design: * Five-stage treatment process, outpatient for stages 1 and 5 and inpatient for stages 2 through 4: * Work-up (1 to 2 weeks): Physical examination, heart and lung function tests, imaging tests, blood and/or tumor samples taken. * IV chemotherapy (1 week): Cyclophosphamide and fludarabine to prepare for the new cell infusion. * IV cell infusion and treatment with IL-2 to support the modified cells (4 days). * Recovery (1 to 2 weeks): Recover from effects of chemotherapy and infusion. * Follow-up (every 1 to 6 months): Return to clinic for physical exam, review of side effects, other tests. * Follow-up evaluations will continue to determine the success of the treatment. * Evaluations during the treatment period: * Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. * Blood and urine tests. * Disease evaluation and monitoring on both inpatient and outpatient basis. * Because researchers do not know the long-term side effects of gene therapy, patients will be asked to participate in long-term follow up for up to 15 years. The follow-up will involve yearly physical exams and medical history, and blood collection (3, 6 and 12 months after treatment, and every year after that).
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression
The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients.
The purpose of this study is to determine the safety and toxicity levels of Dose Escalated Sorafenib in the treatment of patients with renal cancer.
Background: * Natural killer (NK) cells are large lymphocytes (a type of white blood cell) that are important in the immune response to cancer. * IL-2 (Aldesleukin) is a substance the body makes that controls the growth and function of many types of cells. The Food and Drug Administration has approved IL-3 for treating metastatic melanoma and kidney cancer. (Metastatic disease is cancer that has spread beyond the primary site.) Objectives: To determine the safety and effectiveness of treating metastatic melanoma and kidney cancer with laboratory-treated NK cells and IL-2. Eligibility: Patients 18 years of age or older with metastatic melanoma or kidney cancer who have previously been treated with high-dose IL-2. Design: * Leukapheresis. Patients under leukapheresis to obtain NK cells for the treatment regimen. Blood is collected through a needle in an arm vein and directed through a cell separator machine where white blood cells are extracted. The rest of the blood is returned to the patient through a needle in the other arm. NK cells are removed from the white blood cells and treated for re-infusion into the patient. * Chemotherapy. Starting 8 days before infusion of the treated NK cells, patients receive intravenous (IV, through a vein) infusions of cyclophosphamide and fludarabine to suppress the immune system. * NK cell infusion. Patients receive a 30-minute IV infusion of NK cells 2 days after the last dose of chemotherapy. * IL-2 therapy. Within 24 hours of the NK cell infusion, patients receive high-dose IL-2 as a 15-minute IV infusion every 8 hours for up to 5 days. A second cycle of IL-2 is given about 14 days after the first. * Blood tests and biopsy. Patients have frequent blood tests during the treatment period and may be asked to undergo a biopsy (surgical removal of a small piece of tumor or lymph node) at the end of treatment to look at the effects of the treatment on the tumor immune cells. * Follow-up evaluation. Patients are evaluated 4-6 weeks after completing treatment. They have a physical examination, scans of tumor sites, blood tests and blood sampling (or leukapheresis) to examine the response to treatment. Patients who improve with treatment return for evaluations every month. Those whose tumor grows again after originally shrinking may receive one additional treatment course.
This study will evaluate the safety and side effects of two experimental vaccines in patients with kidney cancer and determine whether the vaccines "turn on" an immune response to the cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast growth factor 5 (FGF-5) antigen, a protein produced by some cancer cells, and an oil-based liquid called Incomplete Freud's Adjuvant (Montanide ISA-51) that enhances the immune response to the vaccine. Patients 16 years of age and older who have kidney cancer that has spread beyond the kidney or whose primary kidney tumor has been removed within 6 months before entering the study and are at high risk for disease recurrence may be eligible for this study. Patients must have tissue type human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2) or human leukocyte antigen serotype within HLA-A A serotype group (HLA-A3) (determined by a blood test for human leukocyte antigen (HLA) typing) and their tumors must produce the FGF-5 peptide. Candidates are screened with a physical examination, blood and urine tests, electrocardiogram (EKG), tumor biopsy (removal of a small sample of tumor for examination) in patients whose tumor is easily accessible, and scans (computed tomography (CT), bone scans) and x-rays if current scans are not available. Participants are divided into two groups according to their HLA type (HLA-A2 or HLA-A3) to receive the vaccine appropriate for their HLA type. They are then further divided into three groups: 1) Group 1 includes patients who do not need or are ineligible for treatment with interleukin-2 (IL-2), a protein made by certain infection-fighting white cells that helps fight tumors) and patients who have previously had IL-2 therapy; 2) Group 2 includes patients who require immediate treatment with IL-2; and 3) Group 3 includes patients whose cancer has been surgically removed but who are at risk for recurrence. Patients in Groups 1 and 3 receive two peptide injections four times a week every 3 weeks for up to a year, or until their tumor grows (or returns in patients in Group 3) or the side effects are too severe to continue. Tumors are evaluated with a physical examination and scans or x-rays every 12 weeks and blood tests are done every 3 weeks. Patients in Group 2 receive two peptide injections every day for 4 days, along with doses of IL-2 starting the day after the first peptide injection. The vaccines are given as injections under the skin of the thigh. IL-2 is infused through a vein over 15 minutes every 8 hours for up to 12 doses, depending on tolerance. The vaccine and IL-2 are repeated every 10 to 14 days, with tumor evaluations every 2 months. Patients stay in the hospital about 1 week during each treatment cycle to receive the IL-2. All patients undergo leukapheresis, a procedure for collecting large numbers of white blood cells. Blood is collected through a needle in an arm vein and flows through a cell separator machine, where the white cells are extracted. The rest of the blood is returned to the patient through the same needle or a needle in the other arm. The white cells are examined to evaluate how the vaccines change the action of immune cells. Some patients may undergo an additional biopsy of normal skin and tumor or lymph node to look at the effects of the vaccine on the immune cells in the tumor. Patients in Group 1 whose cancer grows and patients in Group C whose cancer returns may be offered IL-2 treatments as given to Group 2 patients, along with the peptide vaccine. If the disease responds to IL-2, the treatment may be repeated after 2 months.
The clinical use of IL-2 is currently limited by development of dose-dependent hypotension (systolic blood pressure (SBP) \< 90 mm Hg). The overall outcome is constant across sites with 20-50% of the patients requiring ICU management because of unresponsive hypotension and hyporeactivity (loss of response to vasoconstrictors). Because of the dose-limiting side effects, the duration of IL-2 dosing is frequently curtailed. Thus, hemodynamic toxicities have limited the usefulness of IL-2 therapy. M40403 has prevented both the hypotension and hyporeactivity associated with IL-2 treatment in preclinical studies. This trial will study the safety and efficacy of M40403 in the prevention or reduction of hypotension in patients receiving IL-2 therapy.
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.
Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known of its toxicity outside of patients with reduced renal function.
Skin toxicity is a frequently observed side effect in the era of "molecularly targeted therapies". Skin toxicity following administration of protein kinase inhibitors such as sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient, resulting in dose reduction and discontinuation of treatment. The mechanisms of skin toxicity induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly understood. Further research is warranted to better understand the pathophysiology of drug-related skin toxicity in this setting and develop correction strategies. This study tests the hypothesis that sorafenib and regorafenib interfere with p63 expression and keratinocyte differentiation and skin remodeling. Eligible study participants will be evaluated clinically for evidence of skin toxicity during their visits to the outpatient Oncology clinics. Study participants will undergo skin biopsies before sorafenib or regorafenib treatment is initiated and once rash develops or 12 weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed in Oncology clinics by the study investigators and clinic support staff. Study participants will undergo both skin biopsies regardless of whether they develop a rash. In patients who develop a rash the most representative lesion will be biopsied. A normal appearing area of skin will be biopsied in participants who do not develop a rash.
Background: Mithramycin is a new cancer drug. In another study, people with chest cancer took the drug 6 hours a day for 7 straight days. Many of them had liver damage as a side effect. It was discovered that only people with certain genes got this side effect. Researchers want to test mithramycin in people who do not have those certain genes. Objectives: To find the highest safe dose of mithramycin that can be given to people with chest cancer who have certain genes over 24 hours instead of spread out over a longer period of time. To see if mithramycin given as a 24-hour infusion shrinks tumors. Eligibility: People ages 18 and older who have chest cancer that is not shrinking with known therapies, and whose genes will limit the chance of liver damage from mithramycin Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Lung and heart function tests * X-rays or scans of their tumor * Liver ultrasound * Tumor biopsy * Participants will be admitted to the hospital overnight. A small plastic tube (catheter) will be inserted in the arm or chest. They will get mithramycin through the catheter over about 24 hours. * If they do not have bad side effects or their cancer does not worsen, they can repeat the treatment every 14 days. * Participants will have multiple visits for each treatment cycle. These include repeats of certain screening tests. * After stopping treatment, participants will have weekly visits until they recover from any side effects.
Background: - Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet been approved for use in combination with gemcitabine and carboplatin. Researchers are interested in determining the safest and most effective dose of this combined form of chemotherapy for solid tumors, particularly for urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis). Objectives: * To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for solid tumor cancers. * To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for urothelial (bladder) cancer. Eligibility: * Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatments. * Individuals at least 18 years of age who have been diagnosed with urothelial cancer that has not responded to standard treatments. Design: * Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. * Participants with urothelial cancer will receive lenalidomide alone for the first 14 days of a 21-day cycle before starting the first full treatment cycle. * All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1 only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the first 14 days of each cycle. Participants will be asked to take aspirin or other medications to prevent the possibility of blood clots. * Participants may receive up to six cycles of treatment with this combination. If after six cycles the cancer has not grown or has shrunk, participants may continue to take lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until the cancer recurs. * Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment. * After the end of the last treatment cycle, participants will have followup visits every 3 months for the next 18 months, then every 6 months for another 18 months, and then yearly.
The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.
Background: The p53 gene normally suppresses tumor growth, but when it is mutated, or damaged, tumors can grow unchecked. In cancers where the p53 gene has mutated, an increased level of p53(overexpression of p53) can be measured in the tumor. Objectives To determine whether advanced cancers that overexpress p53 can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-p53 protein. Eligibility Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond the original site) Patient's tumor overexpresses p53 Patient's leukocyte antigen type is HLA-A 0201 Design Patients undergo the following procedures: Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the anti-p53 protein is inserted into the cells using an inactivated (harmless)virus in a process called transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment. Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) for 1 week to suppress the immune system so that the patients immune cells do not interfere with the treatment. Treatment with anti-p53 cells. Patients receive an IV infusion of the transduced cells containing anti-p53 protein, followed by infusions of a drug called IL-2, which helps boost the effectiveness of the transduced white cells. Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). Patients are evaluated with laboratory tests and imaging tests, such as computed tomography (CT) scans 4 to 6 weeks after treatment and then once a month 3 to 4 months to determine the response to treatment. Patients have blood tests at 1, 3, 6 and 12 months and then annually for the next 10 years.