
Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases
TumorsVertebral 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.

Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases
Neuroectodermal TumorBrain Metastases1 morePrimary Objective: Determine the interindividual range and median of individual maximum tolerated doses of valproic acid administered as one time evening dose in conjunction with a dose oral etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for four different age groups. Secondary Objectives: Determine the qualitative and quantitative toxicity and reversibility of toxicity of valproic acid in conjunction with oral etoposide, To investigate the clinical pharmacokinetics of valproic acid when given in conjunction with oral etoposide, To describe quality of life of patients with relapsed, or progressive central and peripheral nervous system tumors when treated with oral valproic acid and etoposide, To observe and describe the response pattern of progressive central nervous system tumors treated with oral valproic acid and etoposide, To observe and describe event free survival time and overall survival time of patients with relapsed, or progressive central nervous system tumors when treated with oral valproic acid and etoposide, To determine if histone deacetylase activity and topoisomerase expression in lymphocytes of patients is related to valproic acid levels, and To determine, if the individual maximal tolerated dose (iMTD) depends on the initial performance status of the patient in the beginning of the treatment.

MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis...
Brain NeoplasmsBrain Tumor2 moreThe purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for human brain metastasis and primary brain tumors.

A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic...
Hepatocellular CarcinomaLiver NeoplasmsThe purpose of this study is to determine the maximum tolerated dose (MTD) of ThermoDox when used in combination with radiofrequency ablation (RFA) in the treatment of primary and metastatic tumors of the liver.

Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis,...
Adult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities20 moreThis trial is studying the side effects and how well giving cyclophosphamide and busulfan followed by donor stem cell transplant works in treating patients with myelofibrosis, acute myeloid leukemia, or myelodysplastic syndrome. Giving chemotherapy, such as cyclophosphamide and busulfan, before a donor stem cell transplant helps stops the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening

A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory...
Prostate CancerNeoplasm MetastasisThe purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223 in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.

Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal...
Focal DystoniaDystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This disease is very heterogeneous and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary generalized dystonias; however they are ineffective for focal dystonias following brain damage. Cortex stimulation is a present and effective technique used in the treatment of chronic pain and could represent an interesting strategy to treat focal dystonias. This is the aim of the present study.

Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing...
Renal Cell CarcinomaMetastatic DiseaseThe purpose of this study is to see if preoperative administration of Sorafenib reduces the size of the primary kidney tumour in patients with metastatic disease undergoing cytoreductive surgery. The study will also assess the safety of preoperative Sorafenib. The study drug, Sorafenib, will be given to patients preoperatively for 12 weeks. After a 1 week washout period the patient will then have their nephrectomy (kidney removed). Approximately 6 weeks following their nephrectomy, patients will resume on study drug until disease progression.

Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level...
Secondary HyperparathyroidismThis study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.

Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation...
Secondary HyperparathyroidismThe hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly reduces the cost of treatment post transplant.