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

A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma Save

Date Added
June 28th, 2018
PRO Number
Pro00073638
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies, Pancreas
Summary

The purpose of this study is to find out whether patients with pancreatic cancer will live longer when receiving treatment with nab-Paclitaxel and Gemcitabine, a standard chemotherapy regimen, given in combination with a new drug, BBI-608, or live longer when receiving treatment with nab-Paclitaxel and Gemcitabine alone for pancreatic cancer. The length of participation for this study will continue until your doctor feels you are no longer benefitting from your treatment. This study is expected to take 2-3 years to complete. This research is being done to improve on existing treatments for pancreatic cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincal-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

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination with Cetuximab in Patients with Advanced Head and Neck Squamous Cell Carcinoma Save

Date Added
June 12th, 2018
PRO Number
Pro00076144
Researcher
Paul O'brien

Silhouette
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to see whether an investigational drug called CDX-3379 combined with cetuximab, a monoclonal antibody that targets a protein called EGFR, will shrink tumors for subjects with head and neck squamous cell carcinoma (HNSCC). This study is for patients who have been diagnosed with HNSCC and who have previously received cetuximab but who have since experienced progression. Both the investigational drug, CDX-3379, and cetuximab are administered intravenously (into a vein). Subjects can expect to participate in the study for 2 years or longer.

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

Randomized Phase II Clinical Trial of Cisplatin/Carboplatin and Etoposide (CE) alone or in Combination with Nivolumab as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ED-SCLC) Save

Date Added
June 11th, 2018
PRO Number
Pro00079252
Researcher
John Wrangle

Silhouette
Keywords
Cancer, Cancer/Lung, Stage II
Summary

This study is for patients that have been diagnosed with advanced small cell lung cancer. The investigational drug in this study is Nivolumab (OPDIVO). The purpose of this study is to compare any good and bad effects of using nivolumab along with the usual chemotherapy regimen of cisplatin/carboplatin and etopiside to using the usual chemotherapy approach alone. Participants can expect to be in this study receiving drug and chemotherapy for up to a month with follow up for up to 5 years.

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

Work Ability in Young Adult Survivors (WAYS): A Quantitative Investigation Save

Date Added
June 4th, 2018
PRO Number
Pro00077675
Researcher
David Marshall

Silhouette
Keywords
Cancer
Summary

This observational, cross-sectional study will recruit 200 YA survivors. Data will be collected using a web-based interface and will capture physical, psychosocial and cognitive late effects; work ability; work-related outcomes, including labor force participation, occupation, work place characteristics, and educational attainment; survivor characteristics; and cancer diagnosis/treatment information (from clinical records). Inclusion criteria includes: (1) current age 25-34 years; (2) ?2 to <10 years post-cancer diagnosis; (3) not in active cancer treatment (allowing for maintenance or hormonal therapies); and (4) diagnosed with first cancer (any type except types listed in exclusion criteria in section 4.2) at age ?15 years. Must be able to read and understand English to understand and willingly sign informed consent.

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

A PHASE Ib STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (ANTI?PD-L1 ANTIBODY) ALONE OR IN COMBINATION WITH AN IMMUNOMODULATORY DRUG AND/OR DARATUMUMAB IN PATIENTS WITH MULTIPLE MYELOMA (RELAPSED/REFRACTORY AND POST-AUTOLOGOUS STEM CELL TRANSPLANTATION) Save

Date Added
May 22nd, 2018
PRO Number
Pro00075616
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 multiple myeloma. The investigational drug in this study is atezolizumab.The purpose of this study is to test the safety of various combinations of an experimental (not yet approved by the U.S. Food and Drug Administration [FDA] or any other regulatory authority outside the United States) drug called atezolizumab given with daratumumab, lenalidomide, and/or pomalidomide with or without dexamethasone (all approved by the FDA for the treatment of multiple myeloma) at different dose levels and to find out what effects, good or bad, the combination of these drugs has on you. Participants can expect to be in this study for 36 months.

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

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