A Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib VS. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Relapsing on Lenalidomide as Part of First Line Therapy Save

Date Added
September 20th, 2018
PRO Number
Pro00082054
Researcher
Tondre Buck
Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to compare the effects, good and/or bad, of the study drugs pomalidomide, ixazomib and dexamethasone, or the study drugs pomalidomide and dexamethasone, on participants and their multiple myeloma to find out which is better. In this study, participants will get either the study drugs pomalidomide, ixazomib and dexamethasone or the study drugs pomalidomide and dexamethasone. If participants are assigned to the study drugs pomalidomide and dexamethasone and experience progression of their multiple myeloma, they will have the option to receive the study drug ixazomib in combination with the study drugs pomalidomide and dexamethasone.

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

Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent Save

Date Added
September 6th, 2018
PRO Number
Pro00081552
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal
Summary

Patients will complete questionnaires at 5 time points over 24 months (within 60 days of diagnosis, then at 3, 6, 12 and 24 months after diagnosis). Surveys can be done either on paper or online. It is estimated that it will take 45-60 minutes to complete the first questionnaire and 20-30 minutes to complete the 3, 6, 12 and 24 month questionnaires. Information requested will be about the patient's finances and employment, as well as basic demographic information which will be obtained from the patient's medical records. Patients will be asked to provide their contact information to the ECOG-ACRIN Outcomes and Economics Assessment Unit at Brown University, which will administer the surveys.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist) Save

Date Added
August 21st, 2018
PRO Number
Pro00075705
Researcher
Thomas Keane

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Cardiovascular, Drug Studies, Prostate
Summary

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1b Study of SAR650984 (isatuximab) in Combination with Pomalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma Save

Date Added
August 14th, 2018
PRO Number
Pro00078384
Researcher
Amarendra Neppalli

Silhouette
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with Relapsed/Refractory
Multiple Myeloma. The investigational drug in this study is SAR650984 (isatuximab), administered via infusion.The main purpose of of this study is to evaluate the possible risks and the effectiveness of SAR650984 when given together with pomalidomide and dexamethasone (the combination being called the study treatment) in patients with multiple myeloma. Your participation in this study may last up to 8 weeks, or possibly longer if you are responding well to treatment.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized Phase II Study of Anti-PD1 Antibody (MK-3475 (Pembrolizumab)) Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma Save

Date Added
August 9th, 2018
PRO Number
Pro00080885
Researcher
Daniel Reuben

Silhouette
Keywords
Cancer, Cancer/Skin
Summary

This study is for patients that have been diagnosed with Merkel cell carcinoma. The investigational drug in this study is pembrolizumab. This study will compare any good and bad effects of using radiation along with an immunotherapy treatment [MK-3475 (pembrolizumab)] compared with MK-3475 (pembrolizumab) alone. Participants can expect to be in this study for up to 7 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate Cancer Save

Date Added
July 18th, 2018
PRO Number
Pro00080775
Researcher
David Marshall

Silhouette
Keywords
Cancer, Cancer/Genitourinary
Summary

Patients will be randomized to 1 of 2 arms:
ARM 1: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo orally once daily on days 1-30. Treatment repeats every 30 days for up to 6 courses over 6 months in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive oral apalutamide on Days 1-30. Treatment repeats every 30 days for up to 6 courses over 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly thereafter.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

LEAHRN (Late Effects After High-Risk Neuroblastoma) Study Save

Date Added
July 14th, 2018
PRO Number
Pro00080522
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients who have been diagnosed with high-risk neuroblastoma. The purpose of this study is to learn if the treatment you received for your high-risk neuroblastoma has affected your health overtime. Participants can expect to be in this study for up to 12 weeks.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission Save

Date Added
July 2nd, 2018
PRO Number
Pro00079363
Researcher
Brian Hess

Silhouette
Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients who have mantle cell lymphoma. The investigational drugs used in this study are rituxan hycela and rituximab. The purpose of this research study is to determine whether an autotransplant improves survival in MCL patients who have achieved an excellent (MRD-negative) first complete remission (CR). Participants can expect to be in this study for up to 3 years and then followed for up to 10 years to monitor their health.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Knowledge and Delays in Diagnosis of Oropharyngeal Neoplasms Save

Date Added
June 19th, 2018
PRO Number
Pro00078856
Researcher
Amanda Barrett
Keywords
Cancer, Cancer/Head & Neck
Summary

The objective of this study is to determine potential factors that contribute to late-stage diagnosis and treatment of HPV-positive and HPV-negative oropharyngeal tumors. We have developed a voluntary survey that will be given to patients treated at the MUSC Head and Neck Tumor Center. The survey consists of subsections that identify general HPV knowledge, timeline to diagnosis and treatment, educational background, and sociodemographic characteristics. The participating patients will be given the Short Test of Functional Health Literacy (S-TOFHLA) with the survey. The survey and health literacy data will be used to assess correlations between these factors and the patients stage of cancer at diagnosis. This study will also compare a chart review of prospective patients with retrospective chart review of former oropharyngeal cancer patients. The chart review will include data such as: stage of cancer at diagnosis, treatment, sequence of intervention for diagnosis and treatment, type of biopsy, and types of doctors involved in diagnosis and treatment.

Institution
MUSC
Recruitment Contact
Amanda Barrett
(843) 446-2234
barretam@musc.edu

Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study Save

Date Added
June 12th, 2018
PRO Number
Pro00077962
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer, Lung, Pulmonary
Summary

Physicians currently have difficulty getting a biopsy of lung spots that are far out from the center of the lung. The bronchoscopes that are used to reach these spots currently are sometimes difficult to maneuver and are unable to reach far to these spots because of the large size of the bronchoscope. This study will test a new robotic scope that uses navigation software to find the distant spots in the lung so physicians can get a biopsy.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

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