Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN)- A Randomized Phase II/III Trial

Date Added
July 5th, 2021
PRO Number
Pro00112123
Researcher
Katherine Morgan

List of Studies


Keywords
Cancer/Gastrointestinal, Gall Bladder
Summary

This study is for patients with gallbladder cancer. The purpose of this study is to compare the usual treatment (surgery plus chemotherapy after) to using chemotherapy both before and after surgery.

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

A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Date Added
February 23rd, 2021
PRO Number
Pro00106203
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of their body. In this study, ASP1951 will be given alone (monotherapy) or combined with pembrolizumab (combination therapy). Both ASP1951 and pembrolizumab will be considered study drug. Pembrolizumab has been approved by FDA for use in patients with skin, lung, cervical cancer, certain cancers of head and neck and other cancers but may not be approved to treat all types of cancer. However, the use of ASP1951 plus pembrolizumab has not been approved by regulatory authorities and is therefore investigational. The study consists of 3 periods: screening (up to 28 days), treatment (up to 48 weeks [16 cycles]) and follow up (up to 45 weeks), followed by an optional re-treatment period for participants that qualify. The re-treatment period will allow participants to receive study drug treatment again for up to 16 additional cycles (approximately 48 weeks), for a maximum total treatment and re-treatment period of 32 cycles (approximately 96 weeks). Both study drugs are administered intravenously (into the vein).This is the first time the investigational study drug ASP1951 is being tested in humans; however, studies in animals showed that the study drug is safe to be tested in humans.

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

A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Date Added
November 6th, 2020
PRO Number
Pro00104900
Researcher
Katherine Morgan

List of Studies


Keywords
Cancer/Gastrointestinal, Pancreas
Summary

This study is for patients with pancreatic cancer. The purpose is to see if researchers can increase the chance of pancreatic cancer staying away by giving them chemotherapy before and after surger

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

A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

Date Added
October 8th, 2020
PRO Number
Pro00104741
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal, Pancreas
Summary

This study is for patients over 70 with metastatic pancreatic cancer. We are doing this study because we want to find out what the best approach to lengthen the lives of "vulnerable" patients over the age of 70 with mPCA is.

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

DULOXETINE TO PREVENT OXALIPLATIN-INDUCED CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II TO PHASE III STUDY

Date Added
July 6th, 2020
PRO Number
Pro00101249
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients receiving oxaliplatin for their cancer treatment. The study is being done to see if duloxetine (either 30 mg or 60 mg) prevents numbness, tingling, and/or pain caused by your cancer treatment with oxaliplatin. The study is being done to see if duloxetine can prevent OIPN (oxaliplatin-induced peripheral neuropathy).

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

Protocol RR3 (CP-03-001), Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC)

Date Added
March 2nd, 2020
PRO Number
Pro00093024
Researcher
D. Thor Johnson

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to find out if we can prolong your survival by delivering the chemotherapy drug through an artery that goes directly into your pancreas and to find out if this experimental approach is better or worse than the usual approach for your pancreatic cancer. All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as radiation therapy for approximately four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16 week treatment course until disease progression at the discretion of the Investigator.

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

RANDOMIZED DOUBLE-BLIND PHASE III TRIAL OF VITAMIN D3 SUPPLEMENTATION IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER (SOLARIS)

Date Added
February 4th, 2020
PRO Number
Pro00096338
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with previously untreated metastatic colorectal cancer. The purpose of the study is to see if adding a new drug to the usual combination of drugs can lower the chance of the colorectal cancer growing or spreading.

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

Creon (pancrelipase) therapy for subjects with exocrine pancreatic insufficiency (EPI) due to pancreatic cancer: A double-blind, randomized, parallel design with 2 dose cohorts of pancrelipase in resected pancreatic cancer subjects and an open-label single dose cohort in non-resected pancreatic cancer subjects

Date Added
December 10th, 2019
PRO Number
Pro00089601
Researcher
Katherine Morgan

List of Studies


Keywords
Cancer/Gastrointestinal, Pancreas
Summary

The purpose of this study is to evaluate the effects of an FDA approved drug called pancrelipase on fat absorption in your body. Pancrelipase is an FDA approved drug that can be used to treat exocrine pancreatic insufficiency, which is a condition where the pancreas organ in the small intestine does not deliver enough digestive enzymes to breakdown food you eat.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults with Colorectal Cancer: The M&M Study

Date Added
October 15th, 2019
PRO Number
Pro00093504
Researcher
Daniel Reuben

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for older adults with colorectal cancer. The purpose is to determine if low muscle mass plays a role in side effects from chemotherapy.

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

A Phase 1 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Date Added
July 23rd, 2019
PRO Number
Pro00088438
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Skin
Summary

The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.

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



-- OR --