Clinical Trials

A NOVEL MODALITY OF CARDIAC CT IN CHARACTERIZATION OF ACUTE INFECTIVE ENDOCARDITIS

Status: closed

Approval Date: 9/11/2009

The purpose of this study is to assess the effectiveness of cardiac CT versus TEE in endocarditis patients.

BRIDGE

Bridging Anticoagulation in Patients Who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (“BRIDGE”)

Status: open and enrolling

Approval Date: 9/9/2009

This clinical research study is being sponsored by a grant from the National Institute of Health. People, who require an interruption of their warfarin therapy because of surgery or a procedure, usually stop taking warfarin about 5 days before the surgery. This is done because it takes about 5 days for the blood thinning effect of warfarin to wear off and be eliminated from the body. Warfarin needs to be stopped in order to prevent too much bleeding from occurring during and after surgery. When warfarin is re-started after surgery, it takes about 5-7 days for the blood thinning effect to return. As a result, during this time period the blood thinning effect of warfarin is less than desired. Since interrupting warfarin before and after surgery reduces the blood thinning effect and may increase the risk for blood clots, some doctors choose to administer a blood thinner that works quickly but also wears off quickly. Use of this short acting blood thinner is referred to as "bridging anticoagulation". At this time, there is no agreement among experts and practicing physicians regarding whether bridging anticoagulation should be used. Some doctors give bridging anticoagulation to prevent the formation of blood clots during interruption of warfarin, however some doctors do not give bridging anticoagulation because it might cause bleeding during (or after) surgery. This research study aims at determining the effectiveness and safety of giving a low molecular weight heparin (LMWH) called dalteparin (Fragmin®) as bridging anticoagulation to people with atrial fibrillation who require temporary interruption (stopping for a short time) of warfarin because of surgery or another procedure. It is not known whether bridging anticoagulation is helpful to patients who require temporary interruption of warfarin. On the one hand, bridging anticoagulation minimizes the time patients are not receiving blood thinning treatment prior to and after surgery and therefore may reduce their risk for developing a stroke or other types of blood clots. On the other hand, giving bridging anticoagulation may increase the risk for bleeding, which may be harmful. Such bleeding may require medical attention and may lead to other health problems. Overall, there is uncertainty about the benefit and harm of bridging anticoagulation. This research study is being done to help determine the possible benefits and harms of bridging anticoagulation and will inform doctors about the best way to care for patients in the future.

SWOG S0777 A RANDOMIZED PHASE III TRIAL OF CC-5013 (LENALIDOMIDE, NSC-703813) AND LOW DOSE DEXAMETHASONE (LLD) VERSUS BORTEZOMIB (PS-341, NSC-681239), LENALIDOMIDE AND LOW DOSE DEXAMETHASONE (BLLD) FOR INDUCTION, IN PATIENTS WITH PREVIOUSLY UNTREATED MUL

Status: open and enrolling

Approval Date: 8/26/2009

This randomized phase III trial is studying giving lenalidomide and dexamethasone together with bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma.

The Urinary Tumor Marker (Kidney Injury Molecule-1 Or Kim-1) For The Detection Of Renal Cell Carcinoma

Status: open and enrolling

Approval Date: 8/17/2009

This is a study to identify a non-invasive urinary biomarker (KIM-1) that can be used to screen, diagnose and monitor renal cancers. The study will investigate how urine KIM-1 and a routine blood marker for renal failure (creatinine) can distinguish kidney tumors from non- tumor kidney injuries.  There will be a control group who demonstrate normal serum creatinine and no radiological evidence of a renal tumor (25 patients) and a kidney cancer group (25 patients) that demonstrate a normal serum creatinine and radiological evidence of a renal mass. The control group should not have significant risk factors for kidney disease e.g. diabetes or HTN, and the kidney cancer group cannot have had previous therapy for renal cell carcinoma, or tumor metastasis.

S0715: Prevention of Taxane Induced Neuropathy

SWOG S0715: Randomized Placebo-Controlled Trial of Acetyl L-Carnitine for the Prevention of Taxane Induced Neuropathy

Status: open and not enrolling

Approval Date: 8/7/2009

The purpose of this study is to compare the effects, good and/or bad, of the dietary supplement Acetyl L-Carnitine (ALC) with placebo on neuropathy, to find out which is better. Neuropathy (a side effect of taxane based drugs) is a feeling of pain, numbness, and tingling in the extremities, and a reduced ability for the extremities to function properly. There will also be a comparison of the effects of ALC with placebo on fatigue (tiredness) which is also a side effect of taxane-based drugs. Patients will get either ALC or placebo – not both. ALC is the naturally occurring acetyl ester of the amino acid L-carnitine and plays multiple roles in nerve cell health by optimizing nerve cell energy production and function. Patients will receive ALC (the study drug), or placebo (which contains no drug). Patients will take two capsules three times a day for 24 weeks, complete quality of life surveys at six timepoints and be followed for a total of two years.