Treatment Trials

22 Clinical Trials for Various Conditions

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RECRUITING
Pancreatic Cancer Detection Consortium
Description

This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.

RECRUITING
An Investigational Scan (68Ga-FAPI-46 PET/CT) for the Imaging of Cancer-Associated Fibroblasts in Patients With Localized Pancreatic Ductal Adenocarcinoma
Description

This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts (CAFs) in patients with pancreatic ductal adenocarcinoma (PDA) that has not spread to other parts of the body (localized). CAFs are a type of connective tissue cell that are found within or near cancerous tissue. Many CAFs express a protein called fibroblast activation protein (FAP) that are not found on healthy cells in large amounts. 68Ga-FAPI-46 is a radioactive chemical compound designed to circulate through the body and attach itself to FAP on PDA cells. A PET/CT scan is then used to detect the location of FAP lesions. PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional (3-D) views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.

RECRUITING
A Study to Determine if the Drug, Pyrvinium Pamoate, is Safe and Tolerable in Patients With Pancreatic Cancer
Description

This phase I trial studies the side effects and best dose of pyrvinium pamoate for the treatment of pancreatic ductal adenocarcinoma that cannot be removed by surgery (resectable). Pyrvinium pamoate may slow down tumor growth and help patients live longer.

ACTIVE_NOT_RECRUITING
NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
Description

This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.

TERMINATED
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
Description

This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may help predict the effectiveness of anticancer therapy

Conditions
Advanced Adult Primary Liver CancerCarcinoma of the AppendixFallopian Tube CancerGastrointestinal Stromal TumorLocalized Extrahepatic Bile Duct CancerLocalized Gallbladder CancerLocalized Gastrointestinal Carcinoid TumorLocalized Resectable Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerMetastatic Gastrointestinal Carcinoid TumorOvarian SarcomaOvarian Stromal CancerPrimary Peritoneal Cavity CancerRecurrent Adult Primary Liver CancerRecurrent Adult Soft Tissue SarcomaRecurrent Colon CancerRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerRecurrent Gastric CancerRecurrent Gastrointestinal Carcinoid TumorRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Pancreatic CancerRecurrent Rectal CancerRecurrent Small Intestine CancerRecurrent Uterine SarcomaRegional Gastrointestinal Carcinoid TumorSmall Intestine AdenocarcinomaSmall Intestine LeiomyosarcomaSmall Intestine LymphomaStage 0 Non-small Cell Lung CancerStage I Adult Soft Tissue SarcomaStage I Colon CancerStage I Gastric CancerStage I Non-small Cell Lung CancerStage I Ovarian Epithelial CancerStage I Ovarian Germ Cell TumorStage I Pancreatic CancerStage I Rectal CancerStage I Uterine SarcomaStage II Adult Soft Tissue SarcomaStage II Colon CancerStage II Gastric CancerStage II Non-small Cell Lung CancerStage II Ovarian Epithelial CancerStage II Ovarian Germ Cell TumorStage II Pancreatic CancerStage II Rectal CancerStage II Uterine SarcomaStage III Adult Soft Tissue SarcomaStage III Colon CancerStage III Gastric CancerStage III Ovarian Epithelial CancerStage III Ovarian Germ Cell TumorStage III Pancreatic CancerStage III Rectal CancerStage III Uterine SarcomaStage IIIA Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Adult Soft Tissue SarcomaStage IV Colon CancerStage IV Gastric CancerStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Pancreatic CancerStage IV Rectal CancerStage IV Uterine SarcomaUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder Cancer
COMPLETED
MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Description

RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with stage IV pancreatic cancer that cannot be removed by surgery.

TERMINATED
CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma
Description

This phase Ib/II trial studies the side effects and best dose of CMP-001 and how well it works when given together with INCAGN01949 in treating patients with stage IV pancreatic cancer and other cancers except melanoma. CMP-001 is made up of a short piece of DNA that is packaged in a protein, known as a virus-like particle (VLP). VLPs are detected and processed by cells of the immune system. The DNA contained in CMP-001 activates the immune system and recruit cells of the immune system to the tumor. INCAGN01949 is an antibody, a type of protein, which has been shown to stimulate the immune system. Injecting CMP-001 and INCAGN01949 directly into the tumor may work against tumor cells to slow tumor growth by causing tumor cells to die.

ACTIVE_NOT_RECRUITING
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
Description

This phase IB trial evaluates the effect of niraparib and TSR-042 in treating patients with BRCA-mutated breast, pancreas, ovary, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as TSR-042, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and TSR-042 may kill more cancer cells.

COMPLETED
Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
Description

This phase II trial studies how well ultrasound-guided verteporfin photodynamic therapy works for the treatment of patients with solid pancreatic tumors that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to other places in the body (advanced). Photodynamic therapy is a type of laser device that is guided by ultrasound imaging and used in combination with the drug verteporfin that may be less invasive and as effective as current treatment methods for patients with pancreatic cancer.

ACTIVE_NOT_RECRUITING
GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery
Description

This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or without gemcitabine hydrochloride may kill more tumor cells.

COMPLETED
UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
Description

RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in treating patients who have metastatic pancreatic cancer that has not responded to treatment with gemcitabine.

COMPLETED
UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Description

Phase I trial to study the effectiveness of combining UCN-01 with gemcitabine in treating patients who have unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may help gemcitabine kill more cancer cells by making tumor cells more sensitive to the drug

ACTIVE_NOT_RECRUITING
IExosomes in Treating Participants with Metastatic Pancreas Cancer with KrasG12D Mutation
Description

This phase I trial studies the best dose and side effects of mesenchymal stromal cells-derived exosomes with KrasG12D siRNA (iExosomes) in treating participants with pancreatic cancer with KrasG12D mutation that has spread to other places in the body. iExosomes may work better at treating pancreatic cancer.

COMPLETED
Selumetinib Sulfate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12R Mutations
Description

This phase II trial studies how well selumetinib sulfate works in treating patients with pancreatic cancer with Kirsten rat sarcoma (KRAS) G12R mutations that has spread from where it started to nearby tissue or lymph nodes or other places in the body. Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

COMPLETED
Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
Description

This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy.

Conditions
Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage 0 Gastric Cancer AJCC v8Clinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage I Gastric Cancer AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage II Gastric Cancer AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIA Gastric Cancer AJCC v8Clinical Stage IIB Gastric Cancer AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage 0 Gastric Cancer AJCC v8Pathologic Stage I Esophageal Adenocarcinoma AJCC v8Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage I Gastric Cancer AJCC v8Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IA Gastric Cancer AJCC v8Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IB Gastric Cancer AJCC v8Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage II Gastric Cancer AJCC v8Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIA Gastric Cancer AJCC v8Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIB Gastric Cancer AJCC v8Pathologic Stage III Esophageal Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage III Gastric Cancer AJCC v8Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIA Gastric Cancer AJCC v8Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIB Gastric Cancer AJCC v8Pathologic Stage IIIC Gastric Cancer AJCC v8Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Stage 0 Colorectal Cancer AJCC v8Stage 0 Pancreatic Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage I Pancreatic Cancer AJCC v8Stage IA Pancreatic Cancer AJCC v8Stage IB Pancreatic Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Pancreatic Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIA Pancreatic Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIB Pancreatic Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8
ACTIVE_NOT_RECRUITING
Predicting Effective Therapy in Pancreatic Cancer
Description

The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.

UNKNOWN
Efficacy and Safety Study of PBI-05204 in Patients With Stage IV Metastatic Pancreatic Adenocarcinoma
Description

This study evaluates the efficacy and safety of PBI-05204, an extract of the leaves of Nerium oleander, in patients with Stage IV metastatic pancreatic cancer. All patients will receive PBI-05204.

COMPLETED
Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection
Description

This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be studied. Also, the effects of PEGPH20 on tumors will be studied.

COMPLETED
TKM 080301 for Primary or Secondary Liver Cancer
Description

Background: Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas, gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People who have tumors that can be removed by surgery live longer than those whose cancer cannot be removed. Chemotherapy can shrink some tumors in the liver, which also helps people to live longer, and sometimes chemotherapy can shrink tumors enough that they can be removed by surgery. However, most chemotherapy drugs do not work well on tumors in the liver. In this study we are testing a new drug, TKM-080301, given directly into the cancer blood supply in the liver circulation, to see if it will cause tumors to shrink. Objectives: - To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not responded to standard treatments. Eligibility: - Individuals at least 18 years of age who have inoperable cancer that has started in or spread to the liver. Design: * Participants will be screened with a medical history and physical exam. They will also have blood tests, and imaging studies. * Participants will have a liver angiogram (type of X-ray study) to look at the blood flow in the liver and to place a catheter for delivery of the TKM080301. * Participants will have a single dose of TKM-080301 given directly into the liver. After the drug has been given, the catheter will be removed. They will have frequent blood tests and keep a diary to record side effects. * Participants may have two more doses, each dose given 2 weeks apart. {Before each dose, participants will have another angiogram and catheter placement.}They may also have liver biopsies to study the tumors. * Two weeks after the third treatment (one full course), participants will have a physical exam, blood tests, and imaging studies. If the tumor is shrinking, they may have up to three more courses of the study drug. * Participants will have follow up visits every 3 months for 2 years after the last course and then every 6 months as required.

COMPLETED
Study to Evaluate Efficacy of CO-1.01 as Second Line Therapy for Gemcitabine-Refractory Stage IV Pancreatic Adenocarcinoma
Description

The purpose of this study is to determine whether CO-1.01 is safe and effective for treating metastatic pancreatic cancer that did not respond to gemcitabine.

COMPLETED
A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
Description

The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.