Clinical Trials Actively Recruiting Patients With Glioblastoma


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The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with newly diagnosed or recurrent glioblastoma multiforme. The studies include pilot, phase I, I/II, III, and observational trials investigating chemoradiation therapy; MET/PET scans in predicting response to therapy; standard and new chemotherapies; vaccine therapy; high-dose vitamin C in combination with standard therapy; and molecular profiling to guide treatment. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

 

PILOT

Study Type: Phase 0/interventional/single-group assignment

Study Title: Pilot Study of MET-PET (L-[Methyl]-11C Methionine Positron Emission Tomography) to Evaluate for Treatment Response After Chemoradiation Therapy for Newly Diagnosed Glioblastoma

Study Sponsor and Collaborators: Massachusetts General Hospital

Purpose: To evaluate whether MET-PET scans have value in predicting response to standard chemoradiation therapy in patients with newly diagnosed glioblastoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Effect of 11C methionine PET on progression-free survival (time frame: 2 years)

Principal Investigator: Kevin Oh, MD, Massachusetts General Hospital; 617-724-1159, koh2@partners.org.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01867593


 

Study Type: Pilot/interventional/parallel assignment

Study Title: TORC1/2 Inhibitor INK128 Before and After Surgery in Treating Patients With Recurrent Glioblastoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To investigate how much TORC1/2 inhibitor INK128 reaches the brain tumor and how well it works when given before and after surgery in treating patients with glioblastoma that has grown or recurred and requires surgery.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Proportion of patients who achieve a drug concentration ≥ 70 nM in contrast-enhancing tumor tissue (time frame: up to 2 years)

Principal Investigator: Eudocia Lee, MD, MPH, Dana-Farber Cancer Institute; 866-790-4500 

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02133183


 

Study Type: Pilot/interventional/single-group assignment

Study Title: A Study to Evaluate Vascular Normalization in Patients With Recurrent Glioblastoma Treated With Bevacizumab Using [11C] Temozolomide PET and Vascular MRI

Study Sponsor and Collaborators: Massachusetts General Hospital; National Cancer Institute

Purpose: To investigate how the blood vessels in a patient’s tumor change from treatment with bevacizumab and how these changes affect the way the tumor absorbs temozolomide

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To assess temozolomide delivery before and after bevacizumab in glioblastoma (time frame: 2 years)

Principal Investigator: Tracy Batchelor, MD, Massachusetts General Hospital; 617-724-8770, tbatchelor@partners.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01987830.


 

Study Type: Pilot/interventional/single-group assignment

Study Title: Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Newly Diagnosed Glioblastoma

Study Sponsor and Collaborators: Mayo Clinic; National Cancer Institute

Purpose: To test vaccine therapy and temozolomide in patients with newly diagnosed glioblastoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Incidence of significant toxicity, defined as grade 3 or higher adverse event that is possibly, probably, or definitely related to treatment measured using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (time frame: up to 84 days)

Principal Investigator: Ian Parney, MD, PhD, Mayo Clinic. Contact: Clinical Trials Referral Office; 855-776-0015

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01957956


 

PHASE I

Study Type: Phase I/interventionalsingle-group assignment

Study Title: Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects

Study Sponsor and Collaborators: University of Miami

Purpose: To test whether dendritic cell vaccine is safe and feasible in patients with high-grade glioma

Ages Eligible for Study: 13 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Number of subjects experiencing adverse events (time frame: 5 years)

Principal Investigator: John Goldberg, MD, University of Miami; jgoldberg2@med.miami.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01808820


 

Study Type: Phase I/interventional/single-group assignment

Study Title: Dose-Finding and Safety Study of PVS-RIPO Against Recurrent Glioblastoma

Study Sponsor and Collaborators: National Cancer Institute; Brain Tumor Research Charity Grant

Purpose: To determine the maximally tolerated dose and dose-limiting toxicity of PVS-RIPO when delivered intracerebrally by convection-enhanced delivery. To estimate progression-free and overall survival in patients with supratentorial resectable, recurrent WHO grade IV malignant glioma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose (time frame: 28 days post administration of PVS-RIPO)

Principal Investigator: Allan Friedman, MD, Duke University Medical Center. Contact: Karen Carter, 919-668-2329; Karen.carter@duke.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01491893


 

Study Type: Phase I/interventional/single-group assignment

Study Title: Phase I Trial of a Measles Virus Derivative Producing CEA (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme

Study Sponsor and Collaborators: Mayo Clinic; National Cancer Institute

Purpose: To study the side effects and best dose of viral therapy in treating patients with recurrent glioblastoma multiforme

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Toxicity profile as assessed by National Cancer Institute CTC version 3.0

Principal Investigator: Evanthia Galanis, MD, Mayo Clinic. Contact: Clinical Trials Referral Office, 855-776-0015

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00390299


 

Study Type: Phase I/interventional/single-group assignment

Study Title: A Phase I Study of MLN0128 and Bevacizumab in Patients With Recurrent Glioblastoma and Other Solid Tumors

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and best dose of MLN0128 when given in combination with bevacizumab in treating patients with glioblastoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose/recommended phase II dose of MLN0128, determined according to incidence of dose-limiting toxicity as graded using the National Cancer Institute CTCAE version 4.0 (time frame: 28 days)

Principal Investigator: Lakshmi Nayak, MD, Dana-Farber Cancer Institute

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02142803


 

Study Type: Phase I/interventional/nonrandomized/single-group assignment

Study Title: A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme
Study Sponsor and Collaborators: University of Iowa; National Institutes of Health; National Cancer Institute

Purpose: To test the safety of adding high-dose ascorbate (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma multiforme

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Number of grade 3, 4, and 5 adverse events (time frame: weekly during therapy for up to 10 months)

Principal Investigator: John M. Buatti, MD, University of Iowa

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01752491


 

Study Type: Phase I/inter­ventional/nonrandomized/parallel assignment

Study Title: Phase I Study of AZD1775 (MK-1775) With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma and Evaluation of Intratumoral Drug Distribution in Patients With Recurrent Glioblastoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To investigate the side effects and best dose of WEE1 inhibitor MK-1775 when given together with radiation therapy and temozolomide in treating patients with newly diagnosed or recurrent glioblastoma multiforme

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose of WEE1 inhibitor MD-1775 with 6 weeks of radiation therapy and temozolomide, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (arm 1); (time frame: up to 6 weeks)

Principal Investigator: Brian Alexander, MD, MPH, National Cancer Institute; 617-724-5200

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01849146.


 

PHASE I/II

Study Type: Phase I/II/interventional/randomized/parallel assignment

Study Title: N1174: Phase I/Comparative Randomized Phase II Trial of TRC105 Plus Bevacizumab vs Bevacizumab in Bevacizumab-Naive Patients With Recurrent Glioblastoma Multiforme

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has recurred

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose of TRC105 combined with bevacizumab based on the incidence of dose-limiting toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (phase 1); (time frame: 28 days)

Principal Investigator: Evanthia Galanis, MD, Alliance for Clinical Trials in Oncology; 507-538-7623

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01648348


 

PHASE II

Study Type: Phase II/interventional/single-group assignment

Study Title: A Pilot Trial Testing the Feasibility of Using Molecular Profiling to Guide an Individualized Treatment Plan in Adults With Recurrent/Progressive Glioblastoma

Study Sponsor and Collaborators: University of California, San Francisco; Translational Genomics Research Institute; Ben & Catherine Ivy Foundation

Purpose: To test the feasibility of a specialized tumor board assigning a treatment plan within 35 days of obtaining tumor tissue. The treatment plan will take into consideration each patient’s tumor molecular profile and predictive modeling as well as history and treatment, as well as other medical conditions of the patient.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Feasibility (time frame: 12 months)

Principal Investigator: Michael Prados, MD, University of California, San Francisco; 415-353-2652, pradosm@neurosurg.ucsf.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02060890


 

Study Type: Phase II/interventional/single-group assignment

Study Title: A Phase II Study of the NovoTTF-100A System, Enhanced by Genomic Analysis to Identify the Genetic Signature of Response in the Treatment of Recurrent Glioblastoma Multiforme

Study Sponsor and Collaborators: Washington University School of Medicine

Purpose: To determine how well Novocure’s Tumor Treating Electric Fields (NovoTTF) therapy works in treating patients with recurrent glioblastoma multiforme

Ages Eligible for Study: 22 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Overall response rate (complete response + partial response + stable disease) (bevacizumab naive; time frame: 6 months)

Principal Investigator: David Tran, MD, PhD, Washington State University School of Medicine; 314-362-8967, dtran@dom.wustl.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01954576


Study Type: Phase I-II/interventional/single-group assignment

Study Title: Ketogenic Diet with Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

Study Sponsor and Collaborators: St. Joseph's Hospital and Medical Center, Phoenix

Purpose: To determine if reducing blood sugar and increasing ketones can increase survival and enhance the effects of standard radiation and chemotherapy treatments in newly diagnosed glioblastoma multiforme.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Incidence of adverse events from initiation of ketogenic diet through end of radiation. Secondary Outcome Measures: overall survival time to progression, quality of life.

Principal Investigator: Adrienne C Scheck, PhD, Barrow Neurological Research adrienne.scheck@dignityhealth.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02046187

 



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