Treatment Trials

27 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases
Description

This is a single arm, phase II study without blinding. The purpose is to determine the impact of hepatic artery infusion Floxuridine (FUDR) on liver metastases from pancreatic adenocarcinoma. Patients at Spectrum Health will receive standard of care chemotherapy. They will also receive chemotherapy via surgically placed hepatic artery infusion (HAI) pump.

UNKNOWN
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery
Description

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.

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
CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer
Description

This is an open label, fixed dose, phase Ib trial of anti-CEA CAR-T cell infusions delivered via the hepatic artery or splenic vein using the Surefire Infusion System (SIS) for patients with CEA-expressing liver metastases or pancreas cancer.

TERMINATED
Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases
Description

This study is an open-label, single arm phase 1b safety study of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions for pancreatic carcinoma patients with carcinoembryonic antigen positive (CEA+) liver metastases resistant to standard therapy who meet all other eligibility criteria.

ACTIVE_NOT_RECRUITING
Hepatic Resection for Metastatic Pancreatic Cancer
Description

The purpose of this study is to demonstrate the feasibility of an aggressive multimodal approach among patients with stage IV pancreatic cancer (PAC) with isolated, low-volume hepatic metastasis (LVHM). We will evaluate and describe the surgical and overall outcomes of an initial cohort of subjects who undergo pancreatectomy and hepatic resection/ablation for PAC with LVHM. The end of study results will be reviewed by the Hepatiobiliary Multidisciplinary Conference (HDMC) and Surgery Audit Committee (SAC) to determine the appropriateness of adding this treatment arm for patients with oligometastatic metastatic pancreatic cancer.

COMPLETED
CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases
Description

This is an open label fixed dose phase Ib of anti-CEA CAR-T cells hepatic artery infusions and yttrium-90 SIR-Spheres in patients with CEA-expressing liver metastases.

COMPLETED
Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
Description

Background: Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want to learn the highest dose tolerated. They want to see if getting the agent at surgery helps slow down the disease. Objective: To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the progression of the disease. Eligibility: Adults at least 18 years old with certain cancers and certain blood CA19-9 levels Design: Participants will be screened with: * Medical history * Physical exam * Blood and heart tests * Scans * Review of normal activities * Review of tumor sample * Pregnancy test A few days before surgery, participants will get a dose of the study agent. They will get it through a small plastic tube in a vein over about 2 hours. Participants will sign a separate consent and have the surgery. A sample of the tumor and normal liver will be removed for research. For 1-2 weeks after surgery, participants will recover in intensive care then regular care at the hospital. They will be monitored and treated throughout the stay. After leaving the hospital, participants will get the study agent every week for 1 month. Then they will get it every other week for 2 months. They will repeat screening tests at study visits and at a follow-up visit. That will be about 5 weeks after the last dose.

COMPLETED
Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers
Description

Background: A most common liver cancer in adults is hepatocellular carcinoma. Other kinds of liver cancer happen when colorectal or pancreatic cancer spreads to the liver. Researchers want to study if a combination of drugs helps people with these cancers. The drugs are nivolumab, tadalafil, and vancomycin. Objective: To investigate if nivolumab given with tadalafil and vancomycin causes liver cancer to shrink. Eligibility: Adults ages 18 years and older with hepatocellular carcinoma or metastases to the liver from colorectal or pancreatic cancer for which standard treatment has not worked Design: Participants will be screened with: Medical and cancer history Review of symptoms and ability to perform normal activities Physical exam Heart test. Some participants may meet with a cardiologist and/or have another heart test. Scan of the chest, abdomen, and pelvis Blood and urine tests Tumor sample review. This can be from a previous procedure. Participants will receive the study drugs in 4-week cycles. In each cycle participants will: Get nivolumab through a small plastic tube in the arm on Day 1. Take tadalafil by mouth 1 time every day. Take vancomycin by mouth 4 times a day. They will take it every day for weeks 1 3, then not take it for week 4. Complete a medicine diary of dates, times, missed doses and symptoms. Throughout the study, participants will repeat screening tests and will give stool samples or rectal swabs. After their last cycle, participants will have 3 follow-up visits over 3 months. Then they will be contacted every 6 months by phone or email and asked about their general well-being. ...

WITHDRAWN
Dynamic Contrast Enhanced MRI in Patients With Advanced Breast or Pancreatic Cancer With Metastases to the Liver or Lung
Description

This phase I trial studies the side effects of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in patients with advanced breast or pancreatic cancer with metastases to the liver or lung. Diagnostic procedures, such as DCE-MRI, may help measure a patient's response to treatment

UNKNOWN
Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer
Description

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Poly ICLC may stop the growth of liver cancer by blocking blood flow to the tumor. Giving the drug directly into the arteries around the tumor may kill more tumor cells. Giving cyclophosphamide and radiation therapy together with poly ICLC may be an effective treatment for liver cancer. PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide, radiation therapy, and poly ICLC together and to see how well they work in treating patients with unresectable, recurrent, primary, or metastatic liver cancer.

RECRUITING
Stereotactic Magnetic Resonance Guided Radiation Therapy
Description

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer. * The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer. * Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures

RECRUITING
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Description

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

COMPLETED
A Study of ASN007 in Patients With Advanced Solid Tumors
Description

The study is divided into two parts. The first part of the study will test various doses of ASN007 to find out the highest safe dose to test in five specific groups. The second part of the study will test how well ASN007 can control cancer.

COMPLETED
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms
Description

The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.

COMPLETED
Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver
Description

MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties, making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and provide a treatment to patients with cancers that have spread to the liver.

COMPLETED
Biological Therapy in Treating Patients With Metastatic Cancer
Description

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment.

COMPLETED
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
Description

Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not responded to previous therapy

Conditions
Advanced Adult Primary Liver CancerAnaplastic Thyroid CancerBone MetastasesCarcinoma of the AppendixDistal Urethral CancerFallopian Tube CancerGastrinomaGlucagonomaInflammatory Breast CancerInsulinomaLiver MetastasesLocalized Unresectable Adult Primary Liver CancerLung MetastasesMale Breast CancerMalignant Pericardial EffusionMalignant Pleural EffusionMetastatic Gastrointestinal Carcinoid TumorMetastatic Parathyroid CancerMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterNewly Diagnosed Carcinoma of Unknown PrimaryOccult Non-small Cell Lung CancerPancreatic Polypeptide TumorPrimary Peritoneal Cavity CancerProximal Urethral CancerPulmonary Carcinoid TumorRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Adrenocortical CarcinomaRecurrent Adult Primary Liver CancerRecurrent Anal CancerRecurrent Bladder CancerRecurrent Breast CancerRecurrent Carcinoma of Unknown PrimaryRecurrent Cervical CancerRecurrent Colon CancerRecurrent Endometrial CarcinomaRecurrent Esophageal CancerRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerRecurrent Gastric CancerRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaRecurrent Malignant Testicular Germ Cell TumorRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Pancreatic CancerRecurrent Parathyroid CancerRecurrent Prostate CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Salivary Gland CancerRecurrent Small Intestine CancerRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Thyroid CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerRecurrent Vaginal CancerRecurrent Vulvar CancerSkin MetastasesSmall Intestine AdenocarcinomaSomatostatinomaStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Adrenocortical CarcinomaStage III Bladder CancerStage III Cervical CancerStage III Colon CancerStage III Endometrial CarcinomaStage III Esophageal CancerStage III Follicular Thyroid CancerStage III Gastric CancerStage III Malignant Testicular Germ Cell TumorStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Ovarian Epithelial CancerStage III Pancreatic CancerStage III Papillary Thyroid CancerStage III Prostate CancerStage III Rectal CancerStage III Renal Cell CancerStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Vaginal CancerStage III Vulvar CancerStage IIIA Anal CancerStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Anal CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Adrenocortical CarcinomaStage IV Anal CancerStage IV Bladder CancerStage IV Breast CancerStage IV Colon CancerStage IV Endometrial CarcinomaStage IV Esophageal CancerStage IV Follicular Thyroid CancerStage IV Gastric CancerStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Pancreatic CancerStage IV Papillary Thyroid CancerStage IV Prostate CancerStage IV Rectal CancerStage IV Renal Cell CancerStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IVA Cervical CancerStage IVA Vaginal CancerStage IVB Cervical CancerStage IVB Vaginal CancerStage IVB Vulvar CancerThyroid Gland Medullary CarcinomaUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder CancerUrethral Cancer Associated With Invasive Bladder CancerWDHA Syndrome
COMPLETED
Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer
Description

RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.

Conditions
COMPLETED
Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin with or without floxuridine and leucovorin in treating patients who have metastatic cancer of the peritoneum.

Conditions
TERMINATED
Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery
Description

This randomized phase II trial studies how well everolimus works in treating patients with pancreatic neuroendocrine tumors metastatic to the liver previously treated with surgery. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus after surgery may kill any tumors cells that remain.

TERMINATED
Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors
Description

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Infusing doxorubicin beads into the liver, and blocking blood flow to the tumor, may keep doxorubicin near the tumor and kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of doxorubicin beads and to see how well they work in treating patients with unresectable liver metastases from neuroendocrine tumors.

TERMINATED
Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
Description

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors.

UNKNOWN
A Study to Assess PV-10 Chemoablation of Cancer of the Liver
Description

This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either (a) hepatocellular carcinoma (HCC) that is not amenable to resection, transplant or other potentially curative therapy or (b) cancer metastatic to the liver.

COMPLETED
Advanced MRI Sequences for Radiation Therapy Treatment Planning
Description

The purpose of this study is to determine if it would be helpful to use advanced MRI imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up MRI.

Conditions
COMPLETED
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
Description

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

COMPLETED
Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization
Description

The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.