AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (IND#73789, NSC#732517) in Patients with Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

Date Added
June 22nd, 2012
PRO Number
Pro00016822
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

To collect information about the patient's leukemia and to seek the optimal treatment for children with ALL based on the individual level of risk of the cancer coming back after treatment. The risk groups are defined as a result of recent research conducted by the Children's Oncology Group (COG). We would like to learn if the use of an experimental intrathecal therapy (ITT), which has been given to many people with ALL and has been well tolerated, would be better at preventing relapse in the central nervous system and improve disease outcomes in children with High Risk ALL.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

ANBL12P1: Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients with Newly Diagnosed High-Risk Neuroblastoma

Date Added
July 17th, 2013
PRO Number
Pro00026760
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

the United States, it is standard treatment for patients with high-risk neuroblastoma (NBL) to receive the drugs carboplatin, etoposide and melphalan (CEM) as the preparative regimen in Consolidation therapy prior to Autologous Stem Cell Transplant (ASCT). BuMel Consolidation therapy has recently been studied in patients with high-risk NBL in some European countries. The findings from those studies indicate that the use of BuMel prior to ASCT may be linked to an increase in the survival rate for patients when compared to CEM. Those studies also indicate that the chance of the disease coming back (a relapse) may be lower among the patients who received BuMel Consolidation therapy. In North America the BuMel combination is considered experimental. In this study, researchers want to find out if a combination of busulfan and melphalan (BuMel) can be given as Consolidation therapy prior to ASCT for subjects with newly diagnosed high-risk NBL. The main goal of this study is to find out what effects, good and/or bad, a BuMel preparative regimen given before ASCT has on people with newly diagnosed high-risk NBL.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

ACNS1022: A Phase II Randomized Trial of Lenalidomide (NSC # 703813, IND # 70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytoma and Optic Pathway Gliomas

Date Added
August 23rd, 2013
PRO Number
Pro00026888
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

The overall goal of this study is to find out what effects, good and/or bad, a low
dose and a high dose of lenalidomide have on children, adolescents and young
adults with recurrent (has come back after being treated), refractory (has not gone
away with previous treatment), or progressive (is not responding to previous
treatments) Juvenile Pilocytic Astrocytomas (JPA) and Optic Pathway Gliomas
(OPG).

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

Date Added
April 28th, 2014
PRO Number
Pro00033666
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer/Leukemia
Summary

This study is for adult male and female patients with previously untreated acute myeloid leukemia (AML). The purpose of this study is to compare the effects, good and/or bad of three drug combinations. The first combination is the standard treatment of daunorubicin plus AraC. The second combination is another standard treatment of idarubicin plus AraC. The third combination will add the drug vorinostat to the standard IA therapy. The study team wants to see if the study treatments will get rid of leukemia cells and keep them from coming back for patients who may benefit from stem cell transplant. They also want to find stem cell transplant donors for patients who might benefit from a transplant according to standard practice, beginning at the time patients register for the study. Participants will be asked to take induction treatment for 1-2 months. If a participant gets consolidation, it could take from 1-4 months. Participants may go on to transplant any time in the next year after he/she goes into remission. After participants are finished with the study treatment, the study doctor will ask them to visit the office for follow-up exams for at least 5 years from the time they go into remission.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain

Date Added
September 2nd, 2014
PRO Number
Pro00036590
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Pain
Summary

This study is to evaluate the effects of cognitive behavorial therapy in combination with tDCS (transcranial direct current stimulation) improving chronic pain and functionality, reducing severity of opioid use disorders, improve sleep, and reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD).

Institution
MUSC
Recruitment Contact
Abagail Ault
(843) 792-0291
Ault@MUSC.edu

A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study

Date Added
July 12th, 2016
PRO Number
Pro00056376
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Cancer/Brain, Drug Studies
Summary

Subjects are being asked to volunteer for a research study because they have their first anaplastic astrocytoma (AA) tumor progression (worsening) or recurrence.

The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Eflornithine is an experimental drug that the United States Food and Drug Administration (FDA) has not approved it for use by the general public. Lomustine has been approved by the FDA in the United States for this patient population.

Institution
MUSC
Recruitment Contact
Michele DeCandio
843-792-9016
decandio@musc.edu

Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)

Date Added
August 16th, 2016
PRO Number
Pro00055080
Researcher
Katherine Morgan

List of Studies


Keywords
Diabetes, Digestive System, Insulin, Pancreas, Surgery, Transplant
Summary

The purpose of this research study is to learn more about the outcomes of total pancreatectomy with islet autotransplantation (TPIAT). Total pancreatectomy is the removal of the pancreas and islet autotransplantation is the placement of the insulin producing cells back into you to prevent diabetes. This study is looking to enroll patients who are scheduled to have a TPIAT surgery to treat pancreatitis (inflammation and scarring of the pancreas).

In addition to the routine care for pancreatitis and TPIAT surgery, participation in this study will involve completion of some brief surveys about the subject's health before TPIAT, at 6 months after TPIAT, and each year after the TPIAT surgery for 4 years, as well as a lab test conducted at each of the follow-up visits.

Institution
MUSC
Recruitment Contact
Christine Perez-Rosa
843-792-0387
perezaro@musc.edu

Treatment of Drug-resistant Adult and Pediatric Primary Focal Segmental Glomerulosclerosis Using the LIPOSORBER® LA-15 System

Date Added
January 10th, 2017
PRO Number
Pro00059528
Researcher
Katherine Twombley

List of Studies


Keywords
Blood Disorders, Kidney, Pediatrics
Summary

A device called the "Liposorber LA-15 System" has been approved by the United States Food and Drug Administration for treating kids with focal segmental
glomerulosclerosis (FSGS). The "Liposorber LA-15 System" can only be used if other treatment options, like drugs, don't work or can't be used, but the kidneys are still working okay. It can also be used if the subject has had a kidney transplant and the FSGS comes back after the transplant. Although the Liposorber System can be used for FSGS, we are not sure how well the Liposorber System works. So, we are doing this study to find out how well the treatment works.

In this research study, there will be up to 5 children who have FSGS enrolled at MUSC. Subjects will come back for up to 12 treatments over 9 weeks and then 5 visits to their study doctor over the next 2 years.

Institution
MUSC
Recruitment Contact
Katherine Twombley
843-792-8904
twombley@musc.edu

Targeting Foundational Memory Processes in Nicotine Addiction: A Translational Clinical Neuroscience Study of a Retrieval-Extinction Intervention to Reduce Craving and Smoking Behavior

Date Added
September 5th, 2017
PRO Number
Pro00069355
Researcher
Michael Saladin

List of Studies


Keywords
Smoking
Summary

We recently published results from a NIDA-funded study of a brief behavioral treatment that was designed to reduce the troublesome cravings that smokers encounter when they attempt to quit smoking. This intervention was based on a growing body of neuroscience studies showing that memories for prior learning can be retrieved by the presentation of cues involved in that learning. Once retrieved, the memories enter into a brief period of vulnerability, during which they can be modified, but after which they are reconsolidated (restabilized) back into long-term storage. The treatment potential of this phenomenon was initially demonstrated in a Science report in which inpatient heroin addicts were briefly exposed to cues associated with heroin use in order to prompt the heroin use memories into a vulnerable state. Once the memories were in this state, the heroin addicts received extinction training consisting of protracted exposure to heroin associated cues. It was argued that extinction would change the memories such that the cues would no longer be associated with heroin administration and reward. Remarkably, after just two sessions of retrieval-extinction training (RET), the investigators found that craving in response to heroin cues was substantially reduced for up to 6-months post-treatment. This effect was observed relative to a control group that received retrieval involving non-heroin cues, followed by extinction. These impressive initial findings led us to replicate and extend the study in cigarette smokers. In our study, one group of smokers received two sessions of RET with smoking cues whereas a control group received the same training except that retrieval consisted of brief exposure to neutral, smoking-unrelated cues. Craving and other reactions to familiar and novel smoking cues were assessed in test sessions performed 24-hrs, 2-weeks and 1-month after intervention; smoking behavior was also assessed over 1-month follow-up. Remarkably, at 1-month follow-up, craving to both familiar and novel smoking cues was significantly lower in the group receiving R-E training vs. control. Even more striking was the 25% reduction in the number of cigarettes smoked per day in the RET group vs. control. [Also of significance was suggestive evidence that, relative to control participants, more participants in the RET group achieved a 60% reduction in smoking (from pretreatment levels)]. The proposed project will replicate and extend these findings by 1) increasing the dose of intervention so as to bolster the observed treatment effects, 2) employing brain imaging methods to identify patterns of brain activity uniquely associated with the intervention and potentially predictive of treatment outcome, 3) adding a control group that will enhance understanding of the effects of RET, and 4) extending follow-up period to more completely document the long-term effects of RET. Positive findings from this study could lead to the development of a brief, effective behavioral intervention to reduce the burden levied against society by smoking. Importantly, this intervention could be easily adapted to treat other forms of addiction and co-occurring anxiety disorders, such as PTSD.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-6984
frasibri@musc.edu

Comparison of 0.1 and 0.05mg intrathecal morphine when administered with a multimodal pain regimen for post-cesarean analgesia: a single center, prospective, randomized, single-blinded trial.

Date Added
December 19th, 2017
PRO Number
Pro00072393
Researcher
Katherine Herbert

List of Studies

Keywords
Obstetrics and Gynecology, Pain, Surgery
Summary

This study will compare 0.1mg and 0.05mg of spinal morphine for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a spinal anesthetic (single injection in the lower back to numb patients from the waist down) for operative anesthesia and will be
randomized into one of two groups: (group 1) 0.1mg spinal morphine and (group 2) 0.05mg spinal morphine. This will be a randomized, single blinded study.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu



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