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Neoplasm Metastasis clinical trials

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NCT ID: NCT01287520 Completed - Advanced Cancer Clinical Trials

A Study of LY2090314 in Patients With Advanced or Metastatic Cancer

Start date: November 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B will consist of an expanded cohort to confirm the dose provided from Part A.

NCT ID: NCT01281696 Completed - Breast Neoplasms Clinical Trials

Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis

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

The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and cisplatin in treating breast cancer patients with central nervous system metastasis (including brain parenchymal and leptomeningeal metastasis).

NCT ID: NCT01280032 Completed - Tumors Clinical Trials

Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases

Kypho-IORT
Start date: January 2011
Phase: Phase 2
Study type: Interventional

Vertebral column is the most prevalent location of bone metastases. Besides axial pain, vertebral metastases cause pathological fracture and neurological dysfunction by spinal cord compression. Although the median overall survival of patients with bone metastases is only 7-9 month, half of them live longer and will require palliative treatment for their symptoms. Treatment options are radiotherapy and /or surgical treatment such as laminectomy, vertebroplasty or kyphoplasty. Various studies have shown the superiority of postoperative external beam radiotherapy after kyphoplasty in spinal metastases compared to surgery or radiotherapy alone. Nevertheless postoperative radiation schedules last 2-4 weeks. Moreover many patients present visceral and bone metastases simultaneously and require urgent systemic therapy. However, due to potentiated toxicity, concurrent therapy with full dose chemotherapy and radiotherapy is rarely possible. The investigators have therefore established a novel method for intraoperative radiotherapy (IORT) during kyphoplasty which enables immediate stability, sterilization of the metastasis and immediate initiation of chemotherapy. The kyphoplasty itself is performed according to the standard procedure with some minor modifications. In short under general anaesthesia, a bipedicular approach into the affected vertebra is chosen with insertion of specially designed metallic sleeves to guide the electron drift tube of the miniature X-ray generator (INTRABEAM®). To perform the IORT during a kyphoplasty with this device a new applicator was designed. This sterile applicator consists of a plastic head, which is needed to attach it to the X-ray source and a stainless steel tube. This tube protects the probe from bending. Under fluoroscopic guidance the applicator including the drift tube is guided through the metallic sleeves in the vertebral body. A dose of 8 Gy in 5 mm distance is delivered. After IORT the INTRABEAM system is removed. The kyphoplasty balloon is inflated and PMMA-cement is injected. Afterwards the sleeves are removed and the wound is closed as usual. Aim of this study is the definition of the maximum tolerable dose (MTD) for IORT during a kyphoplasty using specific MTD-criteria and evaluating the effectiveness of this combined treatment procedure. To determine the MTD 3 levels with increasing doses are planned: 8 Gy in 5 mm distance, 8 Gy in 8 mm distance and 8 Gy in 10 mm distance.

NCT ID: NCT01273766 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies

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

RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions. PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies.

NCT ID: NCT01273493 Completed - Clinical trials for Hepatic Insufficiency

A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction

Start date: December 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetics (blood levels) of trabectedin after administration to patients with advanced malignancies and hepatic (liver) dysfunction.

NCT ID: NCT01273480 Completed - Neoplasm Metastases Clinical Trials

A Study to Assess the Potential Effects of Rifampin on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies

Start date: December 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the potential effects of rifampin on blood levels of trabectedin after administration to patients with advanced malignancies.

NCT ID: NCT01270841 Completed - Clinical trials for Secondary Hypogonadism

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

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

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

NCT ID: NCT01267084 Completed - Neoplasm Metastases Clinical Trials

A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies

Start date: February 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the potential effects of ketoconazole on blood levels of trabectedin after administration to patients with advanced malignancies.

NCT ID: NCT01265992 Completed - Clinical trials for Chronic Kidney Disease

Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis

CAPITOL
Start date: February 2011
Phase: N/A
Study type: Observational

Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 & 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden. This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care.

NCT ID: NCT01264952 Completed - Liver Metastases Clinical Trials

Treatment of Liver Metastases With Electrochemotherapy

ECTJ
Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of liver metastases of colorectal cancer in clinical study phase I and II. The study will include 10-15 patients with colorectal cancer with synchronous or metachronous liver metastases, but electrochemotherapy will be performed on metastasis not more than 3 cm in the largest diameter. Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and ultrasonography (US) in a monthly interval. Two or three month after the first operation the treated and untreated metastases will be resected and through histological analyses performed. The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.