Select Ongoing Clinical Trials Currently Enrolling Patients with Brain Cancer

May 2016, Vol 6, No 5 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with brain cancer for inclusion in investigations of new therapies and new regimens of available therapies for patients with brain cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Stereotactic Radiosurgery versus Whole-Brain Radiation Therapy

This randomized, open-label, multicenter, prospective, parallel-assignment phase 3 clinical trial compares stereotactic radiosurgery with whole-brain radiation in patients with newly diagnosed nonmelanoma brain tumors. Men and women aged ≥18 years with histologic proof of metastatic malignant cancer and with between 4 and 10 metastatic lesions may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive stereotactic radiosurgery or whole-brain radiation therapy.

The primary outcome measures are local tumor control (assessed using contrast-enhanced magnetic resonance imaging [MRI] scans) and cognitive decline. This study plans to enroll 100 patients at the University of Texas MD Anderson Cancer Center. For more information, contact Jing Li, MD, at 713-563-2300. The NLM Identifier is NCT01592968.

2 ABT-414 in Patients with Newly Diagnosed Glioblasto­ma and EGFR Amplification

This phase 2b/3, randomized, parallel-assignment, double-blind clinical trial aims to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide prolongs progression-free survival (PFS) and overall survival (OS) in participants with newly diagnosed glioblastoma and epidermal growth factor receptor (EGFR) amplification. Men and women aged 18 to 99 years with a clinical diagnosis of glioblastoma, a confirmed EGFR amplification in tumor tissue, and with a Karnofsky performance score of 70 to 100 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ABT-414, radiation, and temozolomide or placebo, radiation, and temozolomide.

The primary outcome measures are PFS and OS. Some of the secondary outcome measures include the number of days to deterioration in neurocognitive functioning, the number of days to deterioration in symptom severity score, and the number of days to deterioration in symptom interference score. This study expects to enroll 720 patients at multiple locations across the United States and abroad. For more information, contact Kathy Kim, MS, at 847-938-0255 or kathy.kim@abbvie.com; or Kysa Meek at 847-938-1090 or kysa.a.meek@abbvie.com. The NLM Identifier is NCT02573324.

3 Nivolumab versus Temozolomide plus Radiation Therapy in Newly Diagnosed Patients with Glioblastoma

This phase 3, randomized, open-label, parallel-assignment clinical trial is comparing how long patients with glioblastoma live after receiving nivolumab with radiation therapy versus patients receiving standard therapy with temozolomide and radiation therapy. Men and women aged ≥18 years with newly diagnosed brain cancer or glioblastoma, and with a Karnofsky performance score of ≥70 may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab plus radiation therapy or temozolomide plus radiation therapy.

The primary outcome measure is OS at approximately 3 years. The secondary outcome measures are PFS and OS at approximately 24 months. This study plans to enroll 550 patients at multiple locations across the United States and abroad. For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02617589.

4 Efficacy and Safety of Nivolumab versus Bevacizu­mab Alone and of Nivolumab with/without Ipilimumab in Patients with Glioblastoma

This phase 3, randomized, parallel-assignment, open-label clinical trial will compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma, and will evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of glioblastoma therapy. Men and women aged ≥18 years with histologically confirmed grade IV malignant glioma and with a Karnofsky performance score of ≥70 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nivolumab, nivolumab plus ipilimumab, or bevacizumab.

The primary outcome measures are safety and tolerability and OS. The secondary outcome measures include the OS rate, PFS, and the objective response rate. This study plans to enroll 440 patients across multiple locations in the United States and abroad. For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02017717.

5 Local Radiotherapy After Complete Resection of a Brain Metastasis

This phase 3, randomized, multicenter, parallel-assignment clinical trial is assessing whether fractionated local stereotactic radiotherapy will improve local control after complete resection of a single brain while maintaining neurologic functioning, neurocognition, and quality of life. Men and women aged ≥18 years with radiologically confirmed complete resection of a single brain metastasis on a contrast-enhanced MRI within 72 hours after resection and with a World Health Organization (WHO) performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to watchful waiting or to local stereotactic radiotherapy.

The primary outcome measure is local control rate. The secondary outcome measures include a decrease in neurocognitive test results using the Hopkins Verbal Learning Test Revised, a decrease in specified neurocognitive test results using the Trail Making A and B, a decrease in neurocognitive test results using the Controlled Oral Word Association, a decrease in neurocognitive test results using the Wechsler Adult Intelligence Scale (WAIS) III Digit Span and WAIS III Digit Symbol, and a decrease in neurocognitive test results using the Grooved Pegboard. This study expects to enroll 70 patients in the Netherlands. For more information, contact Anna Bruynzeel, MD, PhD, at ame.bruynzeel@vumc.nl; or Frank Lagerwaard, MD, PhD, at fj.lagerwaard@vumc.nl. The NLM Identifier is NCT02729558.

6 Memantine Hydrochloride and Whole-Brain Radiotherapy with/without Hippocampal Avoidance for Reducing Neurocognitive Decline Associated with Brain Metastases

This randomized, open-label, parallel-assignment, phase 3 clinical trial compares the efficacy of memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site to the brain. Men and women aged ≥18 years with brain metastases outside a 5-mm margin around either hippocampus that is visible on contrast-enhanced MRI and with a Karnofsky performance score of ≥70 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive memantine hydrochloride and whole-brain radiotherapy without hippocampal avoidance or memantine hydrochloride and whole-brain radiotherapy with hippocampal avoidance.

The primary outcome measure is time to neurocognitive failure. The secondary outcome measures include health outcomes, incidence of adverse events, intracranial progression, OS, preservation of neurocognitive function, symptom burden, and time to intracranial progression. This study plans to enroll 510 patients at multiple locations across the United States. The NLM Identifier is NCT02360215.

7 Radiation Therapy with/without Temozolomide in Patients with Low-Grade Glioma

The purpose of this phase 3, randomized clinical trial is to assess the efficacy of radiation therapy with or without temozolomide in patients with low-grade glioma. Men and women aged ≥18 years with histologically confirmed supratentorial low-grade glioma, with uncontrolled symptoms (eg, headache associated with mass effect), and with a Karnofsky performance status rating of 60% to 100% may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to undergo radiotherapy only or radiotherapy plus concurrent oral temozolomide.

The primary outcome measures include PFS and OS. The secondary outcome measures include quality of life, neurocognitive functioning, and impact of the presence or absence of 1p and 19q deletion on PFS and OS. This study expects to enroll 540 patients at multiple locations across the United States. The NLM Identifier is NCT00978458.

8 Intraventricular Methotrexate in Children with Recurrent/Progressive Malignant Brain Tumors

The purpose of this phase 2, open-label, single-group clinical trial is to evaluate the use of methotrexate and chemotherapy (topotecan and cyclophosphamide) for recurrent or progressive brain tumors in children aged 0 to 22 years. Patients aged ≤22 years with recurrent or progressive supratentorial or posterior fossa tumors with measurable disease and who have received previous radiation before current recurrence may be eligible for enrollment if other criteria are met. Eligible patients will receive intrathecal methotrexate.

The primary outcome measure is tumor response. The secondary outcome measure is the toxicity of the chemotherapy regimen. This study expects to enroll 10 patients at the Nicklaus Children’s Hospital in Miami, FL. For more information, contact Ziad Khatib, MD, at 305-662-8360 or ziad.khatib@mch.com; or Jenny Esteves at 786-624-2854 or jenny.esteves@mch.com. The NLM Identifier is NCT02684071.

9 Whole-Brain Radiotherapy via Conventional Radiation Therapy versus Intensity-Modulated Radiation Therapy

This randomized, parallel-assignment, open-label, phase 2 clinical trial is assessing whether whole-brain radiation therapy via intensity-modulated radiation therapy (IMRT) results in less hair loss or fewer memory problems compared with standard conventional radiation therapy. Men and women aged ≥18 years with evidence of at least 1 brain metastasis on a gadolinium contrast-enhanced MRI and with a Karnofsky performance score of ≥70 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive whole-brain IMRT or conventional radiotherapy.

The primary outcome measure is alopecia. The secondary outcome measures include tumor growth and quality of life. This study expects to enroll 60 patients at the Good Samaritan Hospital Medical Center in New York. For more information, contact Johnny Kao, MD, at 631-376-4047 or johnny.kao@chsli.org; or Linda M. Reuter at 631-376-3093 or linda.reuter@chsli.org. The NLM Identifier is NCT01890278.

10 Border Zone Stereotactic Radiosurgery plus Bevaciz­umab Therapy in Patients with Glioblastoma Multiforme

This phase 2, open-label, single-group assignment clinical trial is evaluating the efficacy of border zone stereotactic radiosurgery with bevacizumab treatment in patients with recurrent or progressive glioblastoma multiforme. Men and women aged ≥18 years with histologically confirmed glioblastoma multiforme, with a life expectancy of at least 12 weeks, and with a Karnofsky performance score of ≥60 may be eligible for enrollment if other criteria are met. Eligible patients will receive border zone stereotactic radiosurgery and bevacizumab.

The primary outcome measure is OS. The secondary outcome measures include survival at 6 months, CNS toxicity, survival compared with historical outcome, tumor response and radiosurgical toxicity, quality of life, and magnetic resonance spectroscopy. This study plans to enroll 40 patients at the University of Pittsburgh in Pennsylvania. For more information, contact Melinda Vargas-Jaffe, RN, at 412-235-1320 or vargasjaffema@upmc.edu; or Sarah Anderson, RN, at 412-647-8569 or andersonsj3@upmc.edu. The NLM Identifier is NCT02120287.

11 Metformin for Brain Repair in Children with Medulloblastoma Who Underwent Cranial-Spinal Radiation

This randomized, double-blind, crossover-assignment, phase 3 clinical trial is examining whether metformin can enhance cognition or promote brain repair after radiation-induced brain injury. Patients aged 5 to 21 years with medulloblastoma who underwent cranial or cranial-spinal radiation may be eligible for enrollment if other criteria are met. Eligible patients will receive metformin first, followed by a washout period and then placebo, or placebo first, followed by a washout period and then metformin.

The primary outcome measure is the efficacy of metformin in fostering brain repair as measured by tests of thinking and learning. This study expects to enroll 30 patients at The Hospital for Sick Children in Ontario, Canada. For more information, contact Donald Mabbott, PhD, at 416-813-8875 or donald.mabbott@sickkids.ca; or Eric Bouffet, MD, at 416-813-8221 or eric.bouffet@sick kids.ca. The NLM Identifier is NCT02040376.

12 Optune (NovoTTF) plus Bevacizumab and Temozolomide in Patients with Newly Diagnosed Unresectable Glioblastoma

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to assess the efficacy and safety of NovoTTF in combination with bevacizumab and temozolomide in patients with newly diagnosed unresectable glioblastoma. Men and women aged ≥22 years with pathologic evidence of glioblastoma using the WHO classification criteria may be eligible for enrollment if other criteria are met. Eligible patients will receive beva­cizumab, NovoTTF-100A, and temozolomide.

The primary outcome measure is survival at 12 months. This study plans to enroll 46 patients at the Levine Cancer Institute in North Carolina. For more information, contact Sylvia Rushing at 980-442-2346 or Sylvia.Rushing@carolinashealthcare.org. The NLM Identifier is NCT02343549.