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Brain Cancer clinical trials

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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: NCT03152318 Recruiting - Glioblastoma Clinical Trials

A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2

rQNestin
Start date: July 18, 2017
Phase: Phase 1
Study type: Interventional

This research study is evaluating an investigational drug, an oncolytic virus called rQNestin34.5v.2. This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug as a possible treatment for this diagnosis of recurrent or progressive brain tumor.

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: NCT03115398 Completed - Lung Cancer Clinical Trials

A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

Start date: February 16, 2017
Phase: N/A
Study type: Interventional

By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

NCT ID: NCT03072134 Completed - Glioma Clinical Trials

Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma

Start date: April 24, 2017
Phase: Phase 1
Study type: Interventional

Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diagnosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.

NCT ID: NCT03050736 Active, not recruiting - Glioblastoma Clinical Trials

Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression

Start date: December 17, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

NCT ID: NCT03026699 Completed - Brain Cancer Clinical Trials

Refining and Testing the Electronic Social Network Assessment Program (eSNAP)

Start date: May 5, 2017
Phase:
Study type: Observational

The purpose of the study is to learn more about neuro-oncology caregivers' quality of life and how friends and families help neuro-oncology cancer caregivers at different times during treatment.

NCT ID: NCT02941536 Completed - Breast Cancer Clinical Trials

Correlation Between Circulating Tumor Cells and Brain Disease Control After Focal Radiotherapy for Metastases of Breast Cancer

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

This study assesses the number of CTCs before and 4-5 weeks after focal stereotactic radiotherapy, in single or fractionated dose, and correlate with the local and distant brain progression-free survival in patients with metastatic breast cancer.

NCT ID: NCT02911155 Completed - Breast Cancer Clinical Trials

Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists

Start date: September 21, 2016
Phase:
Study type: Observational

Background: The field of nuclear medicine has changed a lot in the past decades. Technology has gotten better, so patients are exposed to less radiation. But now workers are doing procedures more often and using lead aprons less. So they may be exposed to more radiation. This may put them at higher risk for cancers and other health problems that are related to radiation. Researchers want to collect data from technologists to learn more about the risks and appropriate doses of radiation. Objective: To learn more about the risks and appropriate doses of radiation for nuclear medicine technologists. Eligibility: Adults who were first certified in nuclear medicine technology in the United States after 1980. They must be living in the United States. They must not be participants in the USRT study. Design: Participants will be recruited online. Participants will complete an online survey. It will take about a half hour. This will have questions about their work with nuclear medicine procedures. There will be questions about the kinds of procedures and how often they do them. Participants will give a short work history. This will include the names of current and past employers. Participants will allow researchers to get records of their film badge dose readings. These will come from dosimetry providers. Dosimetry data will not be shared with participants. Researchers can t ensure the how accurate or complete the data are.

NCT ID: NCT02861898 Recruiting - Glioblastoma Clinical Trials

Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol). This trial will be a non-randomized open label Phase I/II clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.