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Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).
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A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial Of SonoCloud-9 Combined With Carboplatin (CBDCA) Vs Standard Of Care Lomustine (CCNU) Or Temozolomide (TMZ) In Patients Undergoing Planned Resection For First Recurrence Glioblastoma. (SONOBIRD)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.
Closed for Enrollment
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A Phase 0/Ia Study of BI 907828 Concentrations in Brain Tissue and a Non-randomized Open-label, Dose- escalation Study of BI 907828 in Combination with Radiotherapy in Patients with Newly-diagnosed
Glioblastoma (BI 1403-0007)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.
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A Phase Ib Trial of CB-839 in Combination With Radiation Therapy and Temozolomide in Patients With IDH-Mutated Diffuse Astrocytoma and Anaplastic Astrocytoma
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the side effects and best dose of CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving CB-839 with radiation therapy and temozolomide may work better in treating participants with IDH-mutated diffuse astrocytoma or anaplastic astrocytoma.
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A Phase II Study of Checkpoint Blockade Immunotherapy in Patients With Somatically Hypermutated Recurrent WHO Grade 4 Glioma
Rochester, Minn.,
La Crosse, Wis.,
Jacksonville, Fla.,
Eau Claire, Wis.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma with high number of mutations from growing or spreading compared to usual care (surgery or chemotherapy).
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A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma MIRAGE
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety and tolerability of marizomib in combination with Temozolomide-based radiochemotherapy versus standard Temozolomide-based radiochemotherapy alone in newly diagnosed glioblastoma patients.
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Brain Tumor Repository
Scottsdale/Phoenix, Ariz.
The main objective of the Brain Tumor Repository is to allow access to coded patient data by researchers both inside and outside of the Mayo Clinic system so that important research questions can be answered.
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DB102-01 A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1 (DB102-01)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.
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MEK-NF-201, A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients With Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) That Are Causing Significant Morbidity (RENEU)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate PD-0325901 in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive PD-0325901.
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ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study (ACTION)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to evaluate the effectiveness of ONC201 administered following radiotherapy in participants with H3 K27M-mutant diffuse glioma.
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Phase I/II Combination Study of NMS-03305293 and Temozolomide in Adult Patients with Recurrent Glioblastoma (NMS-03305293)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I), and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).
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Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel® Wafer (Carmustine Implant) Used in Usual Medical Practice (VIGILANT)
Scottsdale/Phoenix, Ariz.
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
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