Clinical Trials at the MFA:

TITLE DESCRIPTION
A Randomized Phase III Trial of Neo-Adjuvant Docetaxel and Androgen Deprivation prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer This randomized trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) This is a study to assess for musculoskeletal symptoms through physician evaluation and QOL forms.
A Hookworm Infection Study in Healthy Adults This study is being conducted to determine the optimal dose of infectious hookworm larvae that is safe to give to healthy adults, and that leads to an infection with adult worms in the intestine. Hookworm is a parasitic worm that can live for several years in the intestine of humans, feeding on the blood of the people they infect. Study participants will provide routine stool and blood samples and will receive anti-worm medication 3 months from application of the larvae to treat the infection. This study is looking to enroll males or females, 18-45 years of age in good general health, who are available for the duration of the study (6 months). Subjects must be HIV, Hep-B and Hep-C negative.
A Phase 2, Double-Blind Study of Ipilimumab Administered at 3mg/kg vs 10mg/kg in Adult Sujbects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic. The primary objective of this study is to estimate the radiographic progression-free survival of patients with chemotherapy-naïve castrate resistant prostate cancer patients randomized to ipilimumab 3mg/kg vs 10mg/kg
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. This is a randomized trial to determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS-25 or less) by Oncotype DX®.
A Phase III, Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer Men with newly diagnosed metastatic hormone sensitive prostate cancer and a PSA =2 ng/mL with be randomized to either Androgen deprivation therapy (LHRHa) + TAK-700 (ARM 1) or Androgen deprivation therapy (LHRHa) + Bicalutamide (ARM 2, also the standard of care arm). Patients will be followed for 10 years.
An Acromegaly Safety Monitoring Program for Treating Patients with Pasireotide LAR who are in need of Medical Therapy (ACCESS Study) This study will provide acromegalic patients, for whom medical therapy is appropriate, access to paseriotide LAR while regulatory approval is sought. Potential patients must: -be age 18 or older -have confirmed diagnosis of active acromegaly (caused by GH producing pituitary tumor) -not be controlled by pituitary surgery or not be eligible or refuse surgery
ARN-509-003: A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with non-Metastatic (M0) Castration-Resistant Prostate Cancer This is a randomized (2:1) trial evaluating the safety and efficacy of ARN-509 versus placebo in men with high risk (M0), non-metastatic castraction resistant prostate cancer (NM-CRPC), defined as PSA doubling time (PSADT) = 10 months
BioSET Prefix Study THis study is designed to evaluate the safety and preliminary effectiveness of one coating concentration of Prefix compared to iliac crest bone in approximately 22 skeletally mature subjects diagnosed with degenerative disc disease (DDD) at one vertabral level (L2-S1)
Change for Health (Diabetes management) This study will attempt to determine the most effective way to help economically vulnerable diabetic patients manage their illness. The study will implement two intervention techniques: 1) A community health worker who will personally help patients overvcome obstacles to diabetes self-care and 2) a text messaging program that will send reminders to patients regarding medication, blood sugar and blood pressure monitoring. Some patients may be assigned to receive both intervention techniques.
Combination immunotherapy with Herceptin and the HER2 vaccine E75 in low and intermediate HER2- expressing breast cancer patients to prevent recurrence This is a randomized trial for after all neo or adjuvant therapy is complete for women are Her2 1+ or HER2 2+
Controlled Trial of Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) The goal of this study is to complete the first definitive controlled trial of a neurosurgical procedure for a severe psychiatric illness. The study will compare the effects of three months of double-masked placebo versus active DBS on OCD severity. Potential participants must: -be between the ages of 18 and 75 -have OCD diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV) -have persistence of sever symptoms and impairment for five years or more despite at least three first-line and two second-line treatments.
DuraSeal Exact Spine Sealant System Post-Approval Study This multi-center, non-randomized, two-arm, Post Approval Study will further evaluate the rate of postoperative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant for treatment of either an intentional or incidental opening of the dura compared to Control patients who receive other products and/or treatments to close the dura. Subjects must be 18 years of age or older and have had a spinal procedure where a dural opening (whether intentional or incidental) occured and was treated with either: -DuraSeal Exact Spine Sealant System (DuraSeal Sealant arm ONLY) or - Any other method of sealing the dura with the exception of DuraSeal Sealant- either spinal or cranial (Control arm ONLY)
Effect of Saxagliptin as a cellular biomarker for evaluating Endothelial Dysfunction in Early Type 2 Diabetes Patients The primary objective of this study is to ascertain if saxagliptin improves endothelial dysfunction in early type 2 diabetes patients. We are looking for patients with Type 2 Diabetes who have no major complications and hemoglobin A1C between 6.0% and 9.0%. Patients also need to be taking Metformin for their diabetes but NOT insulin. This study will take place over four months and include a total of four visits to the MFA. Potential patients must be between the ages of 40 and 70 years old, have Type 2 Diabetes, be taking metformin ONLY for diabetes for at least 3 months, have a Hemoglobin A1C greater than or equal to 6.0% and a Body Mass Index (BMI) between 25.0 and 40.0.
Exenatide Study of Cardiovascular Event Lowering (EXSCEL) This is a clinical study evaluating the investigational use of once-weekly exenatide in reducing the risk factors associated with heart attack or stroke in people with Type 2 Diabetes. Potential participants must: -be 18 years of age or older -have type 2 diabetes -be seeing a doctor routinely at least twice a year for diabetes care -have had a heart attack, stroke coronary revascularization (balloon and/or stent), carotid or peripheral arterial disease -have cardiovascular risk factors such as smoking habit, high blood pressure, elevatyed triglycerides or be overweight -not have previously taken exenatide or similar medication
Prospective Study to Evaluate the Lateral Lumbar Interbody Fusion Surgical Approach (LLIF Prospective Study) The objective of this study is to gather clinical data and satisfaction ratings from patients who have undergone the MIS LLIF surgical approach using the Patriot TransContinental, CALIBER-L or INTERCONTINENTAL LLIF Spacer and REVOLVE Stabilization System for qualifying patients with 1-2 contiguous levels of degenerative disc disease (L2-S1) with mechanical low back pain and radicular symptoms. A total of 45 patients between 18 and 80 years of age will be enrolled and followed for 2 years with data collection preoperatively and postoperatively.
Responsive Neurostimulator System (RNS) Long Term Treatment Investigation This study os designed to assess the ongoing safety and to evaluate the long-term effectiveness of adjunctive RNS therapy in reducing siezures that are refractory to two or more antiepileptic medications.
Retrospective Study to Assess the lateral Lumbar Interbody Fusion (LLIF) Surgical Approach (LLIF Retrospective Study) This will be a retrospective clinical study involving 80 patients that underwent Lateral Lumbar Interbody Fusion and Posterior Pedicle Screw Fixation using the PATRIOT TransContinental or CALIBER-L LLIF Spacer and REVOLVE or REVERE Stabilization Systems.
S0931:A Phase III Trial of Everolimus for Renal Cell Ensuing Surgical Therapy This study is for renal cancer patients who have undergone full surgical resection (radical nephrectomy or partial nephrectomy). Patients must be considered pathologically either intermediate hight risk or very high risk for recurrence.