Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer
Brain MetastasesTo observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
Medical Treatment Decision Making Using Adaptive Conjoint Analysis
CancerBrain Tumor3 moreIn the setting of progressive or recurrent cancer, adolescent and young adult (AYA) patients, parents, and healthcare providers (HCP) are faced with multiple therapeutic options. Each treatment option has a unique risk/benefit ratio, resulting in a need to trade one desirable outcome for another or accept acute toxicities and treatment-related morbidity to increase the chance of survival. Adding to the complexity of this decision, stake holders characterize and value the risk/benefit ratios differently. This study seeks to learn what things are important to an adolescent or young adult with cancer, parents, and health care providers when making decisions about their treatment choices. PRIMARY OBJECTIVE: To quantify the relative importance of various factors believed to be important to adolescent and young adult patients with cancer, parents, and health care providers when choosing between treatment options in the hypothetical situation of progressive or refractory disease.
Biomarker Analysis of Central Nervous System Tumors
Central Nervous System NeoplasmsPrimary Brain Neoplasms4 moreBackground: The number of people who get tumors of the brain or central nervous system (CNS) is lower than other cancers. But these tumors cause a higher rate of serious effects and even death. Researchers want to test existing samples of tissue from these tumors to learn more about them. This may lead to better treatment. Objective: To study stored samples of CNS tumors to learn more about the tumors and explore new ways to diagnose them. Eligibility: The study will use tissue samples already collected at NIH from people with brain or CNS tumors. Design: The participants will have given their consent in a previous study. Researchers will review the tissue samples and any data collected about them. Researchers will do lab tests and scans on the samples. All data will be kept secure.
Neurocognitive Outcome of Conformal WBRT w/wo Hippocampal Avoidance for Brain Metastases
Metastatic Malignant Neoplasm to BrainBrain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness. Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function decline caused by intracranial lesions. By using conventional fractionation, 33% of patients developed late neurocognitive toxicity while memory impairment was the most common symptom. The incidence is even higher when a formal and sensitive neurocognitive assessment was prospectively evaluated. With more long-term survivors nowadays, it has become increasingly important to minimize neurocognitive function decline and maintain quality of life in patients with brain metastasis. The function of hippocampus is cooperation in learning, consolidation and retrieval of information and essential for formation of new memories. Bilateral and unilateral radiation injury of the hippocampus is known to alter learning and memory formation. Several preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is associated with subsequent neurocognitive function impairment in adult and pediatric patients. Furthermore, the preliminary result of Radiation Therapy Oncology Group (RTOG) 0933 suggested hippocampal avoidance significant reduce the mean relative decline at 4 months from 30% in historical cohort with WBRT to 7% in experimental cohort. Previous studies showed brain structures other than hippocampus are also associated with radiation-induced decline in neurocognitive function. There is presence of placebo effect for interventions seeking improvement in neurocognitive function. In present study, a single blind randomized phase II trial is designed to investigate the effectiveness of neurocognitive function preservation using conformal WBRT with or without hippocampal avoidance.
Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During...
Supratentorial NeoplasmsBrain Tumor2 moreFluid management during neurosurgery presents a special clinical agenda. Volume overload can have detrimental effects on intracranial pressure by increasing either cerebral blood volume or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive fluid strategy may risk hemodynamic instability. Recently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have been shown as a more precise parameters for fluid management including in neurosurgical patients. The threshold of SVV is reported about 10-15%. In this study, the investigators aim to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy. Randomization will be generated by computer sampling. One of the two groups of patients will be managed with fluid bolus to keep intraoperative SVV <10% presenting the "normovolemia" group. The other group of patients will be kept intraoperative SVV <18% which is slightly above previously reported SVV threshold upper limit. The second group thus presents the "restrictive" group. Clinical outcomes, laboratory analysis including S100-B for neuronal damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will be compared.
IDH1 Peptide Vaccine for Recurrent Grade II Glioma
Brain CancerBrain Neoplasm5 morePotential subjects with progressive Grade II primary brain tumor that have IDH1 positive testing from the primary tumor (initial diagnosis) will be offered this treatment study in order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy (temozolomide).
Comparator-Controlled Study for EGFR(+) Patients With Multiple BMs From NSCLC (BROKE) (EGFR-epidermal...
Non-Small Cell Lung CancerBrain Metastases1 moreCompare the effect and safety of gefitinib alone with gefitinib plus concomitant WBRT(whole-brain radiotherapy ) in treatment of NSCLC patients harboring an EGFR mutation with multiple BM. Verify the failure pattern of NSCLC patients harboring an EGFR mutation with multiple BM. Explore the rescuable therapy after progression of disease.
Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung...
Brain MetastasesNon-small Cell Lung CancerBrain metastases, a common complication,occur in 25-40% of patients with non-small cell lung cancer (NSCLC). Whole-brain radiation therapy(WBRT) and Stereotactic Radiosurgery (SRS) are important approaches to the treatment of brain metastases from NSCLC. Known to us, epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC, especially for EGFR mutation patients. However, due to the lower concentration of tyrosine kinase inhibitors (TKIs) in the cerebrospinal fluid and its inevitable emergence of drug resistance, brain metastases will be refractory or resistant to standard-dose EGFR inhibitors. Icotinib is one agent of EGFR-TKIs. The previous studies have shown that the Icotinib conventional dose (125mg, TID) is far from reached its maximum tolerable dose. It is a challenge whether the further dose escalation of Icotinib will enhance its concentration in cerebrospinal fluid and thereby improve its therapeutic effect. Here the investigators examine the therapeutic effect and side-effect of double dose of Icitinib in treating patients with brain metastases from NSCLC who have suffered from the failure of conventional dose treatment.
Treatment of Recurrent Brain Tumors: Metabolic Manipulation Combined With Radiotherapy
Brain NeoplasmsRecurrent brain tumours are extremely aggressive and despite optimal treatment, median survival is less than two years. One of the standard treatment options in this situation is radiation therapy. Currently there is intense scientific interest concerning the abnormal energy metabolism in cancer cells. All cells require energy in order to function, obtaining 'fuel' molecules such as glucose and fatty acids from the blood stream. Brain tumours exhibit "metabolic reprogramming", meaning that their energy requirements and utilization of fuel molecules are quite different from normal cells. Brain tumour cells are exquisitely dependant on glucose as a source of energy. Animal studies have shown that when these tumours are deprived of glucose they are very sensitive to radiation therapy. In this clinical trial the investigators combine radiation therapy with a low-carbohydrate diet, in patients with recurrent brain tumours. In addition, subjects will receive medication with metformin, a drug usually used to treat diabetes. Metformin inhibits glucose metabolism within cancer cells, and additionally has reported intrinsic anti-cancer activity. Subjects will undergo advanced imaging and hormonal studies before, during and after the trial in order to obtain maximal translational-scientific impact. The hypothesis: The metabolic changes induced by the combination of a moderately-low carbohydrate diet combined with supplementary MCT and metformin therapy will selectively starve tumor cells. While normal brain cells are capable of deriving energy from ketone bodies during glucose restriction, tumor cells remain largely glucose-dependent for energy due to oncogene induced down-regulation of oxidative phosphorylation. While the tumor cells are in this 'vulnerable' state they will be less able to repair the damage induced by ionizing radiation. Short-term implementation of the metabolic intervention (i.e. combined diet and metformin therapy) prior to, during, and after hypofractionated (2 week) radiation therapy is expected to increase tolerability, increase compliance and avoid the chronic metabolic complications associated with extreme carbohydrate restriction diets.
Investigating the Efficacy of Hair Sparing Radiotherapy Treatment to the Whole Brain.
Metastatic Brain CancerTo investigate the use of a scalp sparing technique of radiotherapy treatment designed to treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and re-growth similar and slow. It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will reduce hair loss and increase the speed and evenness of re-growth.