Active clinical trials for "Brain Neoplasms"

Primary Objective: To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a 6-month distant brain relapse rate of less than 30%. Secondary Objectives: Describe the natural history of neurocognitive function for women with brain metastases treated with SRS and HER-2 directed systemic therapy and establish a reference benchmark to generate hypothesis for future design of a phase III trial. Describe patterns of distant brain relapse after SRS for all patients and compare them between (a) patients with 1-3 vs. 4-10 brain metastasis and (b) between patients treated with each systemic therapy regimen Describe patterns of neurologic death Describe patterns of local brain relapse Describe patterns of re-irradiation with WBRT or SRS Describe adverse events

The investigators want to know if using the study drug dexmedetomidine will improve nerve wave readings during neurosurgery. These readings are done many times during surgery while the patient is asleep. The readings look at how nerves are working and let the operating team know if nerves are hurt during surgery. If the readings tell that nerves are not working correctly, the surgeons can help while changing the way of operating. The study drug will be used in addition to the general anesthesia that a patient is given. The nerve readings that the investigators get while using the study drug will be compared with nerve readings that the investigators get while not using the study drug. The study hypothesis is that dexmedetomidine does not change nerve readings.

Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care. The advantages of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelet makes it a safe medication to use for neurosurgical patients after craniotomy. The primary objective of the study is to observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic response (measurement of B.P and H.R) during extubation.

HITC001 is a single institution study to evaluate the efficacy of using a standardized protocol of surgery and radiation for patients with brain metastases in relapsed neuroblastoma.

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

This is an open-label, non-randomised, phase II study to evaluate the efficacy of neratinib in combination with SOC systemic therapy on CNS metastasis both as for secondary prevention (cohort 1), primary treatment (cohort 2) and for the treatment of LM disease (cohort 3) in subjects with HER2 positive metastatic BC. Subjects with metastatic HER2 positive breast cancer will be eligible for the trial and will be enrolled in one of the following cohorts: Cohort 1: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy and pre-treated with local approaches at least for the previous CNS event and currently progressive but locally treated CNS metastasis. Local therapy includes: stereotactic radiosurgery (SRS) or/and WBRT or/and surgery. The study will measure the effect of the drug combination on the time to next CNS event(s). Cohort 2: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy or progressing less than 12 months after end of adjuvant therapy with a first diagnosis of brain metastases. The study will measure the objective CNS response in each subject. Cohort 3: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy with confirmed LM defined as the presence of malignant cells in the cerebrospinal fluid (CSF) or combination of typical symptoms and MRI. The study will measure the effect of the drug combination on the time to CNS progression including LM progression. As per investigator's choice, eligible subjects in all cohort will receive neratinib in combination with capecitabine or with T-DM1 or with paclitaxel or with vinorelbine as per investigator's choice. Trastuzumab can be added as per investigator's choice to those regimens except for T-DM1. At screening and during the study treatment period (every 9 weeks), brain MRI for cohort 1 and cohort 2 or contrast-enhanced neuraxis brain and spine MRI for cohort 3 and tumour assessment by thoracic and abdomino-pelvic CT scan for all cohorts should be performed. For cohort 3 only, CSF cytological assessment should also be performed. Additionally, at screening and at each cycle during the study treatment period, subjects must fill quality of life questionnaires: EORTC core questionnaire (QLQ-C30) and brain module (QLQ-BN20).

Patients with single brain metastasis without other metastatic site have a better prognosis, and they need a better brain metastasis control. For non-resectable and non-radiosurgical brain metastasis, the gold standard treatment is whole-brain irradiation with 30 Gy in 10 fractions, but the local control is not achieved in most of the cases. This study investigate the possibility to increase radiation dose in this metastasis with exclusive hypofractionated stereotactic radiotherapy.

The primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a tracor of cell proliferation, using Positron Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50 patients with different type of brain tumors.[F-18]FLT PET imaging will be compared to the current used imaging techniques of MRI, spectroscopy imaging, PET imaging using [11C]MET tracer, immunohistochemical analysis and clinical parameters.

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying magnetic resonance imaging in response to radiation therapy in patients with high grade glioma.

Extent of resection is a very important prognostic factor affecting survival in individuals diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma tumor cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts at total resection. The investigators propose to identify the borders of malignant gliomas intraoperatively using oral 5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and thereby provide an opportunity for more complete tumor resection. When exogenous 5-ALA is provided at increased concentration the tumor cells will become fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively and facilitates complete resection. The following data will be collected: Dose-limiting toxicity data Tumor fluorescence assessed by neurosurgeon (0 to +++) in three distinct areas of fluorescence (Strong fluorescence, Weak fluorescence, No fluorescence) Tumor density from biopsies obtained by the neurosurgeon in the same three distinct areas of fluorescence and assessed by neuropathology (Solid tumor, Tumor mixed infiltrating normal brain, No tumor) Neurosurgeon's intra-operative estimate of residual tumor Neuroradiologist's estimate of post-operative residual tumor on MRI Time to progression by MRI Survival (time to progression, one year survival rate and total survival This trial will evaluate: The toxicity of a single dose of oral 5-ALA given pre-operatively. The sensitivity and specificity of 5-ALA - Protoporphyrin IX (Pp IX) as an intraoperative fluorescent detection agent and aid for resection of tumor tissue remaining in the walls of the resection cavity of primary and recurrent malignant brain tumors. The relationship of the neurosurgeon's estimate of the extent of malignant glioma resection (as guided by tumor fluorescence) to the actual extent of resection determined by post-operative imaging. The time-to-progression, one year survival rate and total survival as a function of the extent of resection. Following completion of the phase 1 portion of this trial, an additional 15 subjects will be entered at the recommended phase 2 dose level in order to further define the above parameters at the recommended phase 2 dose level.