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Neoplasm Metastasis clinical trials

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NCT ID: NCT01442935 Completed - Colorectal Cancer Clinical Trials

Chemotherapies Associated With Targeted Therapies on the Resection Rate of Hepatic Metastases

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according to K-Ras status of the patient's tumor. The secondary objectives are to evaluate the objective response rate (CR and PR) after 4 cycles of treatment, according the RECIST V1.1 evaluation scale. - the rate of complete remission (CR) at 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle). - the specific rates of resection R0, R1, R2. - the complete pathological response Rate, - the relapse-free survival rate in (R0 or R1) resected patients, - the response duration in non-resected patients, - the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be evaluated with the Levi scale, - the post operative complications using the DINDO classification, - the progression-free survival (PFS) and overall survival (OS). The objectives of the biological study are: - to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF, TP53) and genetic amplification related factors (EGFR), - to evaluate patient-related predictive factors in connection with genetic polymorphisms (Fc gamma and VEGF receptors), - to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free and progression-free survival, - to study circulating of tumor cells as prognostic factor for metastatic colorectal cancer, non- resectable at presentation.

NCT ID: NCT01442324 Recruiting - Cholangiocarcinoma Clinical Trials

Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma

Start date: February 2011
Phase: N/A
Study type: Interventional

Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

NCT ID: NCT01441596 Completed - Breast Neoplasms Clinical Trials

Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

Start date: October 2011
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

NCT ID: NCT01441115 Terminated - Cancer Clinical Trials

ECI301 and Radiation for Advanced or Metastatic Cancer

Start date: September 6, 2011
Phase: Phase 1
Study type: Interventional

Background: - ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer that has spread in the body (metastatic). Objectives: - To test ECI301 with radiation therapy for advanced or metastatic cancer. Eligibility: - People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy. Design: - Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies. - All participants will have radiation therapy 5 days a week for 2 weeks. - They will have different doses of ECI301 to test its safety and effectiveness. ECI301 will be given in a vein during the second week of radiation therapy. Frequent blood tests and imaging studies will monitor the treatment. - After participants have ECI301, tumor samples may be taken from the site that had radiation and another site that did not have radiation. - Follow-up visits will include blood tests and imaging studies.

NCT ID: NCT01439867 Terminated - Clinical trials for Chronic Kidney Disease

Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

Start date: June 22, 2012
Phase: Phase 2
Study type: Interventional

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

NCT ID: NCT01437007 Completed - Clinical trials for Colorectal Cancer With Hepatic Metastases

TKM 080301 for Primary or Secondary Liver Cancer

Start date: August 26, 2011
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT01433497 Completed - Clinical trials for Multiple Sclerosis, Secondary Progressive

Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

NCT ID: NCT01429493 Completed - Bone Metastases Clinical Trials

Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

Start date: February 2013
Phase: Phase 2/Phase 3
Study type: Interventional

In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.

NCT ID: NCT01428895 Recruiting - Cancer Clinical Trials

Femoral Bone Metastases

Start date: March 2009
Phase: N/A
Study type: Interventional

Bone is a common site of metastasis for a range of malignancies. Bone metastases have the potential to cause significant morbidity including pain, impairment of ambulation and reduced functional independence. Previous research has shown that pathological fractures are observed in 9 to 29 percent of patients with long bone metastases, and a high proportion of these require surgical intervention to relieve pain and restore function. The goal of this study is to describe the clinical outcomes of patients with femoral metastases at high risk of pathological fracture. Patients referred for treatment of femoral metastases at high risk of fracture will be followed prospectively after undergoing with surgery (± post-operative radiotherapy), or radiotherapy alone. Patient and disease characteristics, ambulatory status and limb function will be documented before treatment. These Clinical outcomes of participants in each treatment group will be measured 6 weeks after treatment, and 3- and 6 months after enrolment, with particular reference to patient-reported outcomes relating to pain, ambulatory status, limb function and quality of life.

NCT ID: NCT01428219 Terminated - Clinical trials for Prostate Cancer Metastatic

Trial of Cabozantinib (XL184) in Castrate-Resistant Prostate Cancer Metastatic to Bone

Start date: February 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to look at the effects of cabozantinib on castrate-resistant prostate cancer metastatic (cancer that has spread to other parts of the body) to the bone and to learn about any side effects caused by taking cabozantinib.