A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic...
Breast CancerBrain MetastasesPyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.
Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer
Brain MetastasesLung Cancer Metastatic1 moreThe study will use an Ommaya reservoir that drains into brain metastases to deliver activated, autolous dendritic cells to the tumor lesion, for patients who are 18 - 75 years old who have brain metastases from either lung cancer or breast cancer. The primary objective of the study is to evaluate the safety and feasibility of administering DCVax-Direct to patients with metastatic tumors in the brain. The secondary objectives are to determine tumor response, the rate of intracranial recurrence (IR), the rate of neurologic deaths, decline in neuro-cognitive functioning and overall survival. Approximately 10 patients with injectable metastatic brain tumors will be enrolled initially in a dose escalation scheme, with the expectation to enroll a total of 24 patients.
Biomarker Development for Response Prediction by DNA Mutational Analysis
Neoplasm MetastasisThe purpose of this study is to determine whether it is possible to predict response to chemotherapy in patients with metastatic cancer who are treated with irinotecan by determining the mutational profile of the tumor.
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
TumorCancer7 moreThe purpose of this study is to: Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn. Determine if sodium bicarbonate can reduce cancer-related pain.
ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Pain Resulting From Bone MetastasesThe purpose of this enhanced surveillance study ("ESS") is to collect information regarding chronic adverse events that are possibly related to the ExAblate® System ("ExAblate") that are received by InSightec ("InSightec") following PMA approval. This study will examine adverse events reported in patients undergoing the device procedure for the first two years of commercial experience. Other relevant data may be collected as well.
Dynamic Contrast Enhanced MRI in Patients With Advanced Breast or Pancreatic Cancer With Metastases...
Acinar Cell Adenocarcinoma of the PancreasDuct Cell Adenocarcinoma of the Pancreas6 moreThis 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
Sector Irradiation Versus Whole Brain Irradiation for Brain Metastasis
Metastatic Malignant Neoplasm to the Adult BrainMicroneurosurgical resection of intracerebral metastases leads to prolonged survival and relief of symptoms in selected patients. To minimize the risk of intracranial recurrence whole brain irradiation has been established as standard adjuvant treatment in those patients. Sector irradiation resembles a brain - tissue - sparing method by focusing the irradiation in the area of the tumor bed and a surrounding 1mm security margin. The aim of this study is to investigate whether adjuvant "sector""-irradiation following microsurgical resection is equal to adjuvant whole brain irradiation in terms of local control and superior to in terms of quality of life and neurocognitive deficits in a prospective randomized trial.
Single-fraction IMRT Versus External Beam Radiotherapy for Patients With Spine Bone Metastases
PainThis study is a prospective, randomized, monocentre, controlled explorative study in the parallel-group design to determine the pain relief after RT of patients with spinal bone metastases. Thereby two different techniques were evaluated: single fraction IMRT with 1 x 24 Gy versus fractionated RT with 10 x 3 Gy. Prior to their enrolment into the study, the patients will undergo a staging of the vertebral column in connection with their radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After the baseline results have been recorded, the patients will be randomized into one of the two groups: single-fraction IMRT 1 x 24 Gy (n = 30) or fractionated RT 10 x 3 Gy (n = 30). The target parameters will be measured and recorded at baseline, at the end of RT (t1) and twelve weeks (t2) and six months following the end of the irradiation period (t3).
Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC
Asymptomatic Brain Metastases of Non Small Cell Lung CancerThe purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.
Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients
Secondary HyperparathyroidismThis is a single arm, open-labelled study to determine the effectiveness of combination Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients with ESRF on haemodialysis. Patients will be started on PO Cinacalcet 25mg OD + PO/IV active Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per week every 1-4 weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH has reached 2-9x ULN, patient enters maintenance phase. If serum calcium falls below 2.1mmol/L, active Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will be decreased. Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months will be determined