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NCT ID: NCT05590273 Terminated - Brain Cancer Clinical Trials

Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers

AIM 2
Start date: November 3, 2022
Phase: N/A
Study type: Interventional

To conduct a mixed-method Phase Ia Define Trial of caregivers' participation in CALM therapy with post-session surveys and individual exit interviews in order to evaluate suitability and adapt the CALM intervention to the needs of caregivers in neuro-oncology.

NCT ID: NCT03403361 Terminated - Lung Cancer Clinical Trials

Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The aim of this protocol is to refine the accuracy of proton beam therapy (PT) by the use of dual energy computed tomography (DECT), in conjunction with novel iterative image reconstruction algorithms, to more precisely determine the tissue properties through which the proton beam path travels.

NCT ID: NCT03190967 Terminated - Breast Cancer Clinical Trials

T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery

Start date: April 18, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Sometimes breast cancer spreads (metastasizes) to the brain. Researchers want to study new treatments for brain metastases. The drug Temozolomide is approved to treat brain tumors. Researchers want to see if combining it with the drug trastuzumab emtansine (T-DMI) prevents the formation of new metastases in the brain. Objective: To study if Temozolomide with T-DM1 lowers the chance of having new metastases in the brain. Eligibility: Adults at least 18 years old with a human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to the brain and was recently treated with stereotactic radiation or surgery. Design: Participants will be screened with - Medical history - Physical exam - Heart tests - A scan (computed tomography (CT) that makes a picture of the body using a small amount of radiation - A scan (magnetic resonance imaging (MRI) that uses a magnetic field to make an image of the brain - Blood tests. - Pregnancy test. The study will be done in 3-week cycles. All participants will get T-DM1 on Day 1 of every cycle through a small plastic tube inserted in an arm vein. Some participants will also take Temozolomide capsules by mouth every day. Participants will keep a medication diary. During the study, participants will also: - Repeat most of the screening tests. - Answer questions about their general well-being and functioning. Participants will have lumbar puncture at least 2 times. A needle is inserted into the spinal canal low in the back and cerebrospinal fluid is collected. This will be done with local anesthesia and with the help of images. Participants will be asked to provide tumor samples when available. Participants will have a follow-up visit about 1 month after stopping the study drug. They will be contacted by telephone or email every 3 months after that.

NCT ID: NCT03149575 Terminated - Glioblastoma Clinical Trials

VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM

STAR-3
Start date: October 27, 2017
Phase: Phase 3
Study type: Interventional

This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant temozolomide, and bevacizumab and now has progressive disease during or after bevacizumab. A total of up to 180 eligible patients with recurrent/progressive GBM or GS will be randomized to receive either the investigational drug (VAL-083) or "Investigator's choice of salvage therapy" as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients will be randomized to receive VAL-083 at 40 mg/m2 IV on days 1, 2, and 3 of a 21-day treatment-cycle, for up to 12, 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation. Up to 60 patients will be randomized to receive "Investigator's choice of salvage therapy", limited to temozolomide, lomustine, or carboplatin, until they fulfill one of the criteria for study discontinuation. The dose level for Investigator's choice salvage therapy (temozolomide, lomustine, or carboplatin), will be in accordance with the product label or institutional guidelines. In both study arms, interval medical histories, targeted physical exams, neurologic evaluations, complete blood counts, and other laboratory and safety assessments will be performed approximately every 21-days while receiving treatment. Tumor assessments are to be performed approximately every 42 ± 7 days while remaining on study. The study is estimated to last approximately 20 months.

NCT ID: NCT02768337 Terminated - Breast Cancer Clinical Trials

Cambridge Brain Mets Trial 1

CamBMT1
Start date: March 10, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Proof of principle phase 1b / randomised phase 2 study of afatinib penetration into cerebral metastases for patients undergoing neurosurgical resection, both with and without prior low-dose, targeted radiotherapy.

NCT ID: NCT02692898 Terminated - Brain Cancer Clinical Trials

Biomarker Analysis of Central Nervous System Tumors

Start date: February 25, 2016
Phase:
Study type: Observational

Background: 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.

NCT ID: NCT02370563 Terminated - Brain Cancer Clinical Trials

PET Imaging of Intracranial Cancers With 18F-FSPG

Start date: November 2014
Phase: Phase 1
Study type: Interventional

The aim of this study is to explore the efficacy of 18F-FSPG in the detection of primary or metastatic brain cancer lesions confirmed by a standard of truth, preferably histology. This is a single center, open labelled, non-randomized study. A total of 30 subjects with brain tumor or brain metastases will be enrolled. All different stages of malignancies will be recruited, including those with different types of pathologies and grades, and newly diagnosed or recurrent disease.

NCT ID: NCT02047747 Terminated - Brain Cancer Clinical Trials

A Phase II Study of Dacomitinib in Progressive Brain Metastases

Start date: February 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the disease response, survival, and side effects of an experimental drug called dacomitinib in progressive brain metastases.

NCT ID: NCT01987193 Terminated - Prostate Cancer Clinical Trials

Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy (DS01)

Start date: July 2012
Phase:
Study type: Observational

The purpose of this study is the development of noninvasive (having no direct contact) detector and electronic system that will directly measure tumor blood flow rate.

NCT ID: NCT01902771 Terminated - Glioma Clinical Trials

Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors

Start date: September 3, 2013
Phase: Phase 1
Study type: Interventional

DC vaccine manufactured and partially matured using our standard operating procedures, developed in collaboration with the HGG Immuno Group, then administered through imiquimod treated skin will be safe and feasible in children with refractory brain tumors. This will result in anti-tumor immunity that will prolong survival of subjects treated and results will be consistent with the outcomes found for subjects treated by HGG Immuno Group investigators. Study treatment will correlate with laboratory evidence of immune activation. Correlative studies will also reveal targets in the immune system which can be exploited to improve response for patients on successor trials.