Technology Enhanced Behavioral Activation Counseling (eBAC) by Nurses: Feasibility Study for Depressed Cancer Patients + save

Date Added
August 6th, 2013
PRO Number
Pro00017486
Researcher
Berry Anderson
Keywords
Cancer, Depression
Summary

The purpose of this study is to evaluate nurse delivered behavioral counseling to depressed cancer patients. The oncology nurse will use mobile devices (smartphones & tablets) to enhance behavioral activation counseling.

Institution
MUSC
Recruitment Contact
Berry Anderson
843-792-7739
andersob@musc.edu

Physician Order for Scope of Treatment (POST): PILOT STUDY + save

Date Added
August 6th, 2013
PRO Number
Pro00022252
Researcher
Walter Limehouse
Keywords
Aging, Alzheimers, Cancer, Dementia, Ethnicity and Disease, Geriatrics, Heart, HIV / AIDS, Infectious Diseases, Kidney, Liver, Men's Health, Minorities, Nervous System, Pulmonary, Rare Diseases, Women's Health
Summary

South Carolina Coalition for Care of Serious Illness (SCC CSI) sponsors development of Physician Orders for Scope of Treatment (POST) in South Carolina. The SC POST follows the national POLST (www. polst.org) paradigm creating an advance treatment planning physician order that migrates as valid across institutional boundaries: from physician office, to home/nursing home/hospice to EMS to hospital emergency/inpatient services. The POST form encourages a conversation between a physician and the patient regarding treatment options available to seriously ill patients for whom death within a year would not be a surprise. These choices primarily include whether to attempt cardiopulmonary resuscitation in the event of cardiac or pulmonary arrest or not (a “DNR” or “Allow Natural Death” order) and whether during acute illness to provide full treatment including endotracheal intubation and intensive care, supportive treatment such as noninvasive ventilation and no intensive care, or comfort care only. The Charleston and Greenville areas will pilot POST. Investigators by area will survey providers completing POST documents for patients or treating patients with POST about the utility of this form and how use of the form affected their patient's treatment. A chart reviews of patients presenting with a POST form to a hospital emergency or inpatient unit will address whether providers respected patient treatment choices. SCC CSI plans to publish the results of the pilot in appropriate journals and present the results at medical meetings and to interested persons. The results of the study may provide the supporting documentation for subsequent legislation supporting POST. POST represents a coordinated statement of a seriously ill patient’s treatment choices to be honored across multiple treatment settings.

Institution
MUSC
Recruitment Contact
Walter Limehouse
792-9705
limehouw@musc.edu

PILOT STUDY OF NEOADJUVANT GEMCITABINE AND ABRAXANE CHEMOTHERAPY FOLLOWED BY SURGERY FOR PATIENTS WITH LOCALIZED, RESECTABLE ADENOCARCINOMA OF THE PANCREAS + save

Date Added
August 2nd, 2013
PRO Number
Pro00019035
Researcher
Melanie Thomas
Keywords
Cancer, Cancer/Gastrointestinal
Summary

This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will have screening tests to determine if he or she is eligible to participate in this study. If subjects are eligible and wish to enroll in the study, they will begin chemotherapy treatment with Gemcitabine and Abrazane. After subjects have received treatment with these drugs, they will have surgery. Subjects will also have post treatment and follow up evaluations. Subjects may have 2 cycles of treatment and each cycle is 28 days. All subjects will be followed every 3 months for 3 years after their initial registration.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Comination with OGX-427 in Patients with Relapsed or Refractory Metastatic Urothelial Carcinoma after Receiving Platinum-containing Regimen + save

Date Added
July 23rd, 2013
PRO Number
Pro00026419
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Men's Health, Women's Health
Summary

This study is for subjects who have inoperable (surgical treatment is not an option) or metastatic (has spread to other parts of the body) urothelial carcinoma (includes cancer of the bladder, urethra, ureter or renal pelvis) and who are not responding to platinum-based chemotherapy (such as carboplatin or cisplatin).
This study will evaluate whether treatment with OGX-427 in combination with docetaxel can prolong survival time compared to treatment with docetaxel alone in patients with urothelial carcinoma (UC) who are no longer responding to treatment with a platinum-based chemotherapy regimen. Docetaxel (also known as Taxotere®) is commercially available and is approved by the Food and Drug Administration (FDA) in the United States for the treatment of breast, stomach, lung, prostate and head and neck cancers. OGX-427 is a new drug that is experimental (not approved by the FDA).
The use of docetaxel in combination with the experimental drug OGX 427 in this study is investigational. “Investigational” means that the combination of drugs is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved this combination of drugs.
Subjects in Group A will receive 9 days of loading doses, 10 cycles of combined treatment at 3 weeks per cycle, and maintenance treatment with OGX-427 only until the disease progresses or they experience unacceptable side effects.
Subjects in Group B will receive 10 cycles of docetaxel alone at 3 weeks per cycle, for a total of about 30 weeks. Everyone who completes study treatment with no evidence of disease progression will be followed every 6 weeks until disease progression. Everyone will be followed every 3 months after disease progression for survival.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

A Phase II Randomized, Multicenter Study of Treatment-Free Remission In Chronic Myeloid Leukemia In Chronic Phase (CML-CP) Patients Who Achieve And Sustain MR4.5 After Switching To Nilotinib + save

Date Added
July 23rd, 2013
PRO Number
Pro00025811
Researcher
Robert Stuart
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to find out if the switching to the study drug, nilotinib (Tasigna) (AMN107, Tasigna) in people who have Chronic Myeloid Leukemia (CML) can help decrease the number of leukemia cells to a very small number.
This trial is sponsored by the pharmaceutical company named Novartis.
Eligible subjects will receive nilotinib (Tasigna), the study drug, as CML treatment. Nilotinib (Tasigna) is a medicine which has been approved by the United States Food and Drug Administration (FDA) for the treatment of CML. The duration of the study will range from 2 years and up to 6 years.

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

A Multi-center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow (Haplo) for Patients with Hematological Malignancies + save

Date Added
July 19th, 2013
PRO Number
Pro00019032
Researcher
Luciano Costa
Keywords
Blood Disorders, Cancer, Cancer/Lymphoma, Transplant
Summary

The purpose of this study is to learn more about reduced-intensity transplants that use a mismatched donor. You are being asked to participate in this study because you have a cancer of the blood or lymph glands and a stem cell transplant is a treatment option.

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-8856
simonsjl@musc.edu

Phase II placebo-controlled trial of lisinopril and Coreg CR® to reduce cardiotoxicity in patients with breast cancer receiving (neo)adjuvant chemotherapy with trastuzumab (Herceptin®) + save

Date Added
July 18th, 2013
PRO Number
Pro00005411
Researcher
Amarinthia Curtis
Keywords
Cancer, Cancer/Breast, Drug Studies, Heart, Hypertension/ High Blood Pressure
Summary

The purpose of this study is to compare the effects, good and/or bad, of an ACE inhibitor (lisinopril) or a beta-blocker (Coreg CR® [carvedilol phosphate extended release]) on heart function during treatment with trastuzumab (Herceptin®), a drug subjects will receive as treatment for breast cancer. Lisinopril and Coreg CR® are used to treat high blood pressure, heart failure and in heart attack patients. Study doctors want to find out which treatment (lisinopril or Coreg CR®) is better at protecting heart function during treatment of breast cancer. The effect of the medicines will be compared to a placebo, which contains no active drug. Subjects will only get one of the study medicines (lisinopril, Coreg CR® or placebo).

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab With or Without AMG 386 in Patients With Recurrent Glioblastoma or Gliosarcoma + save

Date Added
July 18th, 2013
PRO Number
Pro00019337
Researcher
Patricia Griffin
Keywords
Brain, Brain Tumor, Cancer, Cancer/Brain, Drug Studies, Glioblastoma
Summary

This randomized phase II trial studies how well bevacizumab given with or without AMG 386 (trebananib) works in treating patients with brain tumor.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

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

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

PHASE I/II TRIAL OF CONCURRENT RAD001 (EVEROLIMUS) WITH TEMOZOLOMIDE/RADIATION FOLLOWED BY ADJUVANT RAD001/TEMOZOLOMIDE IN NEWLY DIAGNOSED GLIOBLASTOMA + save

Date Added
July 16th, 2013
PRO Number
Pro00018913
Researcher
Pierre Giglio
Keywords
Cancer, Cancer/Brain
Summary

This is a study for subjects with glioblastoma brain tumors which have not received treatment other than surgery or biopsy. The purpose of this study is to find out what effects (good and bad) radiation therapy combined with temozolomide and RAD001 (everolimus) have on brain tumors. Before subjects begin study treatment screening procedures will be conducted to ensure subjects are eligible to participate. Subjects will be “randomized” into one of two study groups. Group 1 will receive radiation treatment with temozolomide. Group 2 will receive radiation treatment, temozolomide and RAD001. Subjects will receive treatment for 6 weeks. Subjects will return to clinic for a follow up exam 28 days later. Subjects will then take temozolomide and RAD001 for up to 12 months. They will then be asked to return for follow up exams every 3 months for the first year after treatment, every 4 months for the next year and every 6 months thereafter.

Institution
MUSC
Recruitment Contact
John Keller
843-792-1286
kellej@musc.edu