Clinical Trials

We know ending cancer will require a weapon as adaptable and multiform as the disease itself.
Audacious

We know ending cancer will require a weapon as adaptable and multiform as the disease itself.

Our team at The Preston Robert Tisch Brain Tumor Center understands the need to cross new thresholds when it comes to discovering the cure for brain cancer. Perhaps our most advanced methods of scientific exploration come in the form of clinical trials. While patients who enroll in clinical trials may feel like they are navigating uncharted territories, they are giving scientists an opportunity to unravel maps that can lead to new discoveries, future treatment options, and maybe even a cure.

What Are Clinical Trials?

A clinical trial is a research study involving human participants that aims to understand the effects of a certain drug, device, or treatment. Almost all treatment methods currently available are the product of clinical trials. Patients can enroll in clinical trials only after preclinical studies have been conducted. All clinical trials have a principal investigator (usually a medical doctor) who is in charge of the research staff. The principal investigator also makes sure that the protocol—or the set of rules the clinical trial is based on, such as the length of the trial, eligibility, etc.—is being followed. Through meticulous predesign, clinical trials are set up in a way to answer questions regarding safety, side effects, and benefits of the treatment, as well as whether some people will benefit more than others. There are usually four phases of a clinical trial.

What We Offer

In the past, clinical trials were often perceived as a last resort for brain tumor patients. But here at Duke, we have proven time and again that experimental therapy is often the best option for many of our patients, and could be much more effective than the standard of care treatment. We offer interventional studies for the newly diagnosed and recurrent patients, as well as supportive care studies that explore how to increase the comfort and quality of life for individuals with brain cancer. Below is a list of clinical trials being offered at the Center. Your team at Duke will discuss the best options for you or your loved one.

  • ADULT TRIALS

    Newly Diagnosed 

    Study:  Elevate: Evaluation of overcoming limited migration and enhancing cytomegalovirus-specific dendritic cell vaccines with adjuvant tetanus pre-conditioning in patients with newly-diagnosed glioblastoma                                                            

    PI:  Gordana Vlahovic, MD, MHS 
    Phase:  II 
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at NCT02366728
    IRB number:  Pro0005470 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301 

    Study: A phase I trial for patients with newly diagnosed high-grade glioma treated with concurrent radiation therapy, Temozolomide, and BMX-001

    PI: Katherine Peters, MD, PhD

    Phase: I

    Category: Adult Neuro-Oncology

    Purpose: For detailed information, please view this trial at NCT02655601

    IRB number: 00062660

    Contact: For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301

     

    Study: Study of Temozolomide plus radiation therapy with Nivolumab or placebo, for newly diagnosed patients with glioblastoma (GBM, a malignant brain cancer). (CheckMate548) 

    PI: Gordana Vlahovic, MD, MHS

    Phase: II

    Category: Adult Neuro-Oncology

    Purpose: For detailed information, please view this trial at ClinicalTrials.gov at NCT02667587 

    IRB number: 00071737

    Contact: For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301

     

    Study: Peptide targets for glioblastoma against novel cytomegalovirus antigens (PERFORMANCE) for newly diagnosed GBM

    PI: Dina Randazzo, DO

    Phase: II

    Category: Adult Neuro-Oncology

    Purpose: For detailed information, please view this trial at ClinicalTrials.gov at NCT02864368

    IRB number: 00034208

    Contact: For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301

     

     

     

    Study: Phase 1b, multicenter, open-label study of Marizomib combined with Temozolomide and radiotherapy in patients with newly diagnosed WHO grade IV malignant glioma

    PI: Annick Desjardins, MD, FRCPC

    Phase: II

    Category: Adult Neuro-Oncology

    Purpose: For detailed information, please view this trial at ClinicalTrials.gov at NCT02903069

    IRB number:

    Contact: For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301

  • Recurrent 

    Study:  A phase 1, multicenter, open-label, dose-escalation and expansion, safety, pharmacokinetic, pharmacodynamic, and clinical activity study of orally administered AG-881 in patients with advanced solid tumors, including gliomas, with an IDH1 and/or IDH2 Mutation 

    PI:  Katherine Peters, MD, PhD 
    Phase: 
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at NCT02481154 
    IRB number:  Pro00063389 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301 

    Study:  AVeRT:  Anti-PD-1 monoclonal antibody (nivolumab) in combination with DC vaccines for the treatment of recurrent grade III and grade IV brain tumors 

    PI:  Katherine Peters, MD, PhD
    Phase:  
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at NCT02529072 
    IRB number:  Pro 00065241 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301 

    Study:  RESIST: Patients with IDH-positive recurrent grade II glioma enrolled in a phase I safety and immunogenicity study of tumor-specific peptide vaccine 

    PI:  Katherine Peters, MD, PhD
    Phase:  I 
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov 
    IRB number:  Pro00054746 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301 

    Study:  A phase II study of Sym004 for adult patients with recurrent glioblastoma 

    PI:  Annick Desjardins, MD, FRCPC 
    Phase: II 
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at NCT02540161 
    IRB number:  Pro00063483 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301 

    Study:  Multicenter,  phase 2 trial of single agent Marizomib 

    PI:   Annick Desjardins, MD, FRCPC 
    Phase: II
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at Clinical Trials.gov at NCT02330562
    IRB number:   Pro00059540 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301 

    Study:  Dose-finding and safety study of PVSRIPO against recurrent WHO grade IV malignant glioma 

    PI: Dina Randazzo, DO
    Phase:  I 
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at NCT01491893
    IRB number:  Pro00031169 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301  

    Study:  A phase I single-center, dose escalation study of D2C7-IT administered intratumorally via convection-enhanced delivery for adult patients with recurrent malignant glioma 

    PI:  Dina Randazzo, DO
    Phase:  I
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at  NCT02303678
    IRB number:  Pro00053325 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301 

    Study: A randomized phase 3 open-label study to evaluate the efficacy and safety of Eflornithine with Lomustine compared to Lomustine alone in patients with AA that progress/recur after irradiation and adjuvant Temozolomide chemotherapy (STELLAR)

    PI:  Annick Desjardins, MD, FRCPC
    Phase:  III
    Category:  Adult Neuro-Oncology
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at NCT02796261
    IRB number:  00076758
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301
  • Supportive Care 

    In addition to therapeutic clinical trials, we are also designing clinical trials that focus on the quality of life and supportive care for brain tumor patients. Currently, we have several projects that are actively recruiting participants. 

    In addition to traditional outcomes such as overall survival and progression-free survival, the measurement of patient-reported outcomes of quality of life, physical function, and neurocognitive function is becoming increasingly important in oncology clinical trials.

    Brain tumor patients have a unique set of challenges because they not only have to deal with the consequences of a cancer diagnosis, which requires surgery, radiation treatments, and chemotherapy treatments but also a neurological diagnosis that leads to neurological dysfunction.

    This neurological dysfunction can, in turn, lead to physical limitations and neurocognitive limitations. Therefore, we believe that our patients have immediate oncologic and neurological concerns that make it more challenging to achieve a positive and productive quality of life.

    Our treatments for brain tumors can also limit the quality of life in our patients.  The limitations can include nausea/vomiting, fatigue, problems with thinking, problems with physical function, problems with blood counts, and blood clots in the limbs and the lungs. We are actively recruiting and designing studies to tackle these issues and improve the lives of our patients and their loved ones.

    Supportive Care Clinical Trials

    Study:  A randomized open label phase II trial of aprepitant (Emend) in combination with ondansetron compared to standard 5HT3 serotonin antagonist (Ondansetron) in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in glioma patients receiving a temozolomide-based regimen 

    PI:  Mary Lou Affronti, DNP, RN, ANP, MHSc 
    Phase:  II 
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrial.gov at NCT01450826 
    IRB number:  Pro00031206 
    Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301 

    Study:  A feasibility study to evaluate the efficacy and safety of perampanel in seizure patients with primary glial brain tumors 

    PI:  Katherine Peters, MD, PhD 
    Phase:  IV 
    Category:  Adult Neuro-Oncology 
    Purpose:  For detailed information, please view this trial at ClinicalTrial.gov at NCT02363933
    IRB number:  Pro00055609                                                                                                                                                                                                                                                                                                                        Contact:  For more information, please contact The Preston Robert Tisch Brain Tumor Center at 919-684-5301

     
     

     

  • PEDIATRIC TRIALS

     

    Study:  Developing evidence-based criteria for initiating treatment for neurofibromatosis type I-associated optic pathway glioma 

    PI:  David Van Mater, MD, PhD 
    Phase:  N/A (Observational) 
    Category:  Pediatric Neuro-Oncology 
    Purpose:  To understand the natural history of vision in NF1 patients with an optic pathway glioma and to determine predictors of future vision loss or change in tumor size. For detailed information, please view this trial at ClinicalTrials.gov 
    IRB number:  Pro00066558 
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288

    Study:  The collection of blood samples from patients with NF1 for research purposes 

    PI:  David Van Mater, MD, PhD 
    Phase:  N/A (Biorepository) 
    Category:  Pediatric Neuro-Oncology 
    Purpose:  To augment an existing biobank resource for neurofibromatosis type 1 (NF1) research. For detailed information, please view this trial at ClinicalTrials.gov 
    IRB number:  Pro00068686 
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288

  • Recurrent 

    Study:  PBTC-042: Phase I study of CDK 4-6 inhibitor PD-0332991 in children with recurrent, progressive or refractory central nervous system tumors
     
    PI:  David Van Mater, MD, PhD
    Phase:  I
    Category:  Pediatric Neuro-Oncology
    Purpose:  For detailed information, please view this trial at ClinicalTrials.gov at NCT02255461
    IRB number:  Pro00054303
    Contact:  For more information, please contact Pediatric Neuro-Oncology at 919-684-2288