Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Y-90 is incorporated into very tiny glass beads (microspheres: Therasphere MDS Nordion) and is injected into the liver tumor through the hepatic arteries, which are responsible for the feeding of the neoplastic liver tissue. Since the microspheres are unable to pass through the micro-vasculature of the liver parenchyma and tumor they are trapped at those sites and exert a local radio-therapeutic effect.

Yttrium-90 microspheres (Therasphere MDS Nordion)

Vincenzo Mazzaferro, MD

Rationale: Patients diagnosed with hepatocellular carcinoma (HCC) at an intermediate or advanced stage (according to the BCLC classification system) are not amenable of curative treatment. According to EASL and AASLD guidelines patients with an intermediate stage HCC are treated with trans-arterial chemoembolization (TACE) while patients with an advanced stage HCC are treated with molecular targeted drugs or other combinations according to their liver function. The median survival expected for patients in intermediate-advanced stages ranges from 11 to 20 months.

Purpose of the Study: The purpose of this prospective phase II study is to determine whether or not Radioembolization with Yttrium-90 microspheres (TheraSphere®) provides an anti-tumoral effect and a sensible benefit in terms of time-to-progression (TTP) and survival in patients with good liver function (Child A-B7) and a confirmed diagnosis of Intermediate or Advanced (because of the presence of neoplastic portal thrombosis) Hepatocellular Carcinoma (HCC).

Patients at an intermediate stage (BCLC-B) are currently offered trans-arterial chemoembolisation (TACE) as the standard of care. A recent meta-analysis showed that radioembolization with beta-emitting Yttrium-90-loaded glass microspheres (TheraSphere®) in patients with HCC achieves a median objective response in 79% of cases (range 29-88%) and median survival exceeding 15 months has been reported in patients at intermediate stages who have been treated with TheraSphere®.

In patients with HCC at an advanced stage (BCLC-C) the single treatment that has shown a statistical advantage on overall survival and disease progression is sorafenib, that provides a median survival of 10.7 months. Based on the results reported in literature, the estimated median expected survival of patients with advanced HCC treated by TheraSphere® can be as long as 12 months.

After approval on July 2007 of a treatment protocol of Y-90 for compassionate use by the institutional IRB, at the National Cancer Institute of Milan 40 consecutive patients have been treated with radioembolization with Yttrium-90 microspheres (Theraspheres®) according to the same guidelines of the present prospective phase II protocol. The initial series of 40 patients treated according to a compassionate use of Y-90 has been instrumental for the assessment of the procedure's safety and tolerability. The present study has been targeted to 60 cases including the fist series of 40 "compassionate" patients, due to their adherence to the same inclusion/exclusion criteria of the proposed phase II study.

Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma

Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced HCC (Hepatocellular Carcinoma) Not Eligible to Curative Approach. A Phase II-b Study.

Gastro Intestinal Surgery and Liver Transplantation

The Hepato-Oncology Group: Department of Surgery, Medicine and Radiology

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Dr. Vincenzo Mazzaferro

Rare Diseases

Primary Liver Cancer

Yttrium 90 (TheraSphere)

Kenneth Kolbeck, MD, PhD

Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.

Patients receive Y-90 (yttrium) glass microspheres via percutaneous hepatic arterial infusion. Patients amy be retreated between 30-90 days after initial infusion. After completion of therapy, patients are followed for 30 days and then every 3 months for up to 2 years.

Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option

A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

Oregon Health and Science University

Boston Scientific Corporation

OHSU Knight Cancer Institute

Associate Professor, Charles T. Dotter Department of Interventional Radiology

Symptoms and General Pathology

Neoplasm Metastasis

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Gastrointestinal Agents

Somatostatin

Octreotide

Edotreotide

Antineoplastic Agents, Hormonal

Hormones

Hormone Antagonists

Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of

* renal toxicity
* loss of patient transferability or
* denial of further treatment.

DOTA-TOC Treatment

Martin A Walter, MD, Dr.

The investigators aim to explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and long-term safety profile of systemic \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC treatment in metastasized neuroendocrine cancer patients. Adverse events are assessed according to the criteria of the National Cancer Institute. Survival analyses are performed using multiple regression models.

Background: Systemic treatment with the 90Yttrium (90Y) labeled, tetraazacyclododecanetetraacetic acid (DOTA) modified somatostatin analog Tyr3-octreotide (TOC) was introduced in 1998 (Otte et al. Lancet 1998). \[90Y-DOTA\]-TOC is administered intravenously and binds to the somatostatin receptor subtype 2, located on the surface of the tumor cell, and exerts its cytotoxic effects by β-irradiation. The treatment has moderate acute hematologic and nephrologic toxicity and has developed into a promising therapeutic tool for tumors expressing its target receptor (Iten et al. Clin Cancer Res 2007, Iten et al. Cancer 2009).

Study Aim: To explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer.

Study Hypothesis: Response to DOTA-TOC is correlated with prolonged survival.

Study Type: Clinical phase II, single-center, open-label trial

Patients: 1500 patients

DOTA-TOC in Metastasized Neuroendocrine Tumors

Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors

University Hospital, Basel, Switzerland

Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver

--------------------------------------------------------------------------------

Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver

yttrium Y 90 microspheres (TheraSphere®)

James P Flynn, MD

The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity.

The study has the following objectives:

* Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver.
* Evaluate patient experience and toxicities associated with TheraSphere treatment
* Evaluate predisposing factors that may influence results and toxicity

This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.

1. Range of patients who can be offered TheraSphere®
2. Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
3. Survival time
4. Determine response in relation to histology and other parameters
5. Ability to tolerate repeat treatments
6. Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

Southwestern Regional Medical Center

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Leukemia

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Hematologic Diseases

Chronic Graft Versus Host Disease

Lymphosarcoma

Acute Graft Versus Host Disease

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Patients receive therapy with an yttrium-90 labelled anti-CD66 following favourable dosimetry with the same antibody radiolabelled with indium-111.

Yttrium-90 labelled anti-CD66 monoclonal antibody.

Targeted radiotherapy

Kim H Orchard, MBBS PhD

To determine whether a radiolabelled antibody that targets the bone marrow (the 'anti-CD66') can be administered safely to patients as part of the preparative treatment prior to haematopoietic stem cell transplantation ('a bone marrow transplant'). Can the radiolabelled antibody be shown to effectively target the bone marrow in these patients. If it can, could this result in better outcomes after transplantation.

The aim of this clinical research study is to establish whether a radiolabelled antibody can be used to safely deliver radiotherapy to the bone marrow prior to stem cell transplantation for haematological malignancies.

With current chemotherapy regimens 60-90% of adult patients with acute leukaemia (AML and ALL) achieve a complete remission. However in a significant proportion of these patients the disease will recur. Although allogeneic and autologous bone marrow or peripheral blood haematopoietic stem cell transplantation (HSCT) are established as effective treatment options for haematological malignancies, resulting in long term disease free survival in a significant proportion of patients, the results of transplantation for patients with poor risk disease are disappointing. Further intensification of the treatment used prior to transplantation has been shown to reduce the risk of relapse, but the toxicity of the drugs or external beam radiotherapy causes an increase in transplant related deaths. The introduction of reduced intensity conditioning protocols allows the use of HSCT for older patients or those with significant additional medical problems but retrospective analysis indicates an increased rate of relapse. This is the 'Transplantation dilemma' - how to reduce the risk of disease relapse by intensifying therapy, but without an increase in toxicity to other organs causing an increase in transplant related deaths in remission.

Normal haematopoietic tissue and the malignant cells arising from it are very radiosensitive. Theoretically intensification of the conditioning therapy, particularly total body irradiation (TBI), prior to transplantation could increase tumour reduction leading to improved disease free survival rates for patients with poor risk disease. Targeted radiotherapy could allow treatment intensification without the toxicity to non-haematological tissues. In addition, the continuous, low dose rate delivered by the natural decay of a targeted radionuclide may have a greater destructive effect upon tumour cells than single dose or fractionated external beam radiation.

Targeted Radiotherapy in HSCT for Poor Risk Haematological Malignancy

Radiolabelled Anti-CD66 Monoclonal Antibody in the Conditioning Regimen Prior to Haematopoietic Stem Cell Transplantation: Phase I Study in Patients With Poor-risk Disease.

Trial fully recruited. Data will be summarised upon completion of study.

To determine the maximum tolerated dose (MTD) of targeted radiotherapy delivered by a murine anti-CD66 monoclonal antibody radiolabelled with yttrium-90 (Y-90) and determine the dose-limiting toxicity (DLT) in patients with haematological malignancies who are undergoing haematopoietic stem cell transplantation.

Toxicities are assessed using WHO Toxicity Scale with 28 parameters.

Dosimetry is determined by whole body and SPECT-CT of the thorax and abdomen on days 1, 2, 4 and 5 post infusion of an indium-111 radiolabelled anti-CD66. Dosimetry determines whether patients proceed to therapy with the yttrium-90 labelled anti-CD66.

Royal Free and University College Medical School

University Hospital Southampton NHS Foundation Trust

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma	NCT00910572	Hepatocellular ... Liver Cancer	Yttrium-90 micr...	18 Years - 80 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma	NCT00910572	Hepatocellular ... Liver Cancer	Yttrium-90 micr...	18 Years - 80 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma	NCT00910572	Hepatocellular ... Liver Cancer	Yttrium-90 micr...	18 Years - 80 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option	NCT00740753	Liver Cancer Hepatoma	Yttrium 90 (The...	18 Years -	OHSU Knight Cancer Institute
DOTA-TOC in Metastasized Neuroendocrine Tumors	NCT00978211	Neuroendocrine ...	DOTA-TOC Treatm...	-	University Hospital, Basel, Switzerland
Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors	NCT00493883	Carcinoma, Hepa... Liver Neoplasms	yttrium Y 90 mi...	18 Years -	Southwestern Regional Medical Center
Targeted Radiotherapy in HSCT for Poor Risk Haematological Malignancy	NCT01521611	Acute Leukaemia Chronic Leukaem... Myeloma Lymphoma	Targeted radiot...	18 Years - 75 Years	University Hospital Southampton NHS Foundation Trust
Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma	NCT00910572	Hepatocellular ... Liver Cancer	Yttrium-90 micr...	18 Years - 80 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Spots Global Cancer Trial Database for yttrium

Every month we try and update this database with for yttrium cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for yttrium

Every month we try and update this database with for yttrium cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for yttrium cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.