Select Clinical Trials Currently Enrolling Patients with Brain Cancer

May 2017, Vol 7, 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 or new regimens of existing treatments for patients with brain cancer. Each description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to an appropriate clinical trial.

1 IDO Inhibitor and Temozolomide for Adults with Primary Malignant Brain Tumors

The objective of this nonrandomized, parallel-assignment, open-label, phase 1/2 clinical trial is to provide a foundation for future studies of indoximod in combination with radiation and temozolomide or in combination with vaccine therapies in patients with newly diagnosed glioblastoma. Individuals aged ≥16 years with histologically proven intracranial glioblastoma multiforme and with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 or Karnofsky performance status of ≥70 may be eligible for enrollment if other criteria are met.

In phase 1b, eligible patients will receive indoximod in an escalating fashion and temozolomide. In phase 2, patients in cohort 2a are bevaciz­umab-naïve and will receive indoximod and temozolomide. Patients in cohort 2b will receive indoximod, temozolomide, and bevacizumab; these patients have previously received bevacizumab. Patients in cohort 2c will receive indoximod with temozolomide and stereotactic radiosurgery.

The primary outcome measure in phase 1 is to determine the phase 2 dosing. The primary outcome measure in phase 1b is to determine the recommended phase 2 dose of indoximod and temozolomide in combination for the treatment of progressive high-grade glioma.

The primary outcome measure in phase 2 is 6-month progression-free survival. The secondary outcome measures include the number of adverse events as a measure of safety and tolerability, the overall dose of temozolomide delivered versus the historical control, pharmacokinetics, and overall response rates.

This study plans to enroll 144 patients at multiple locations across the United States. For more information, contact NewLink Genetics at 515-296-5555. The NLM Identifier is NCT02052648.

2 Temozolomide plus Radiation Therapy with Nivolumab or with Placebo for Newly Diagnosed Glioblastoma: CheckMate-548 Study

This randomized, parallel-assignment, phase 2 clinical trial will compare how long patients with glioblastoma live after receiving temozolomide plus radiation therapy compared with patients receiving nivolumab plus temozolomide and radiation therapy.

Men and women aged ≥18 years with newly diagnosed brain cancer and with a Karnofsky performance status of ≥70 may be eligible for enrollment if other criteria are met. Participants will receive nivolumab plus temozolomide and radiotherapy or placebo plus nivolu­mab and radiotherapy.

The primary outcome measure is overall survival. The secondary outcome measure is progression-free survival. This study expects to enroll 320 patients at multiple locations across the United States and abroad. For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02667587.

3 Trabectedin for Grade II/III Recurrent Meningioma

This randomized, parallel-assignment, phase 2 clinical trial aims to collect data on the activity, toxicity, and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.

Men and women aged ≥18 years who have not received previous systemic antineoplastic therapy for meningioma and with a World Health Organization performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive trabectedin or the local standard of care.

The primary outcome measure is progression-free survival. The secondary outcome measures are progression-free survival at 6 months, best overall response, overall survival, safety, and health-related quality of life. This study plans to enroll 86 patients at multiple locations abroad. For more information, e-mail Tina Verschuere at tina.verschuere@eortc.be. The NLM Identifier is NCT02234050.

4 Abemaciclib plus Surgery for Recurrent Glioblastoma

This nonrandomized, crossover-assignment, phase 2 clinical trial will investigate abemaciclib with surgery in patients with recurrent glioblastoma. Men and women aged ≥18 years with a Karnofsky performance status of ≥60 may be eligible for enrollment if other criteria are met. Patients will receive abemaciclib plus surgery or abemaciclib without surgery.

The primary outcome measure is intratumoral abemaciclib concentration and 6-month progression-free survival. The secondary outcome measures include retinoblastoma protein (pRB) expression level of tumor tissue, the incidence of treatment-emergent adverse events, the area under the plasma concentration versus the time curve, peak plasma concentration, radiographic response, median progression-free survival, and overall survival.

This study expects to enroll 47 patients at multiple locations across the United States. For more information, contact Eudocia Q. Lee, MD, MPH, at 617-632-2166 or eqlee@partners.org, or Sarah Gaffey at 617-632-4341 or sgaffey@partners.org. The NLM Identifier is NCT02981940.

5 Lapatinib plus Temozolomide and Regional Radiation Therapy for Newly Diagnosed Glioblastoma Multiforme

The purpose of this open-label, single-group assignment, phase 2 study is to test the safety and efficacy of lapatinib plus standard radiation therapy and temozolomide in patients with newly diagnosed glioblastoma multiforme.

Men and women aged ≥18 years with a histologically proven intracranial glioblastoma multiforme or gliosarcoma and with a Karnofsky performance status of >60 may be eligible for enrollment if other criteria are met. Eligible patients will receive lapatinib plus temozolomide and radiation therapy.

The primary outcome measure is overall survival. This study plans to enroll 70 patients at the University of California, Los Angeles. For more information, contact Emese Filka at 310-794-3521. The NLM Identifier is NCT01591577.

6 Pembrolizumab for Recurrent Glioblastoma

The purpose of this single-group assignment, phase 2 clinical trial is to assess the efficacy and safety of pembrolizumab in patients with glioblastoma. Men and women aged ≥18 years with grade 4 malignant glioma and with a Karnofsky performance status of ≥60 may be eligible for enrollment if other criteria are met. Eligible patients will receive pembrolizumab.

The primary outcome measure is progression-free survival. The secondary outcome measures include very good partial response, progression-free survival, duration of response, overall survival, time to disease progression, objective response rate, minimal residual disease status, pain inventory, quality of life, and patient-reported outcomes.

This study plans to enroll 240 patients at multiple locations across the United States and abroad. For more information, contact AbbVie Call Center at 847-283-895. The NLM Identifier is NCT02755597.

7 Eflornithine plus Lomustine versus Lomustine Monother­apy in Recurrent Anaplastic Astrocytoma: STELLAR Study

The purpose of this randomized, parallel-assignment, phase 3 study is to compare the efficacy and safety of eflornithine in combination with lomustine compared with lomustine monotherapy in patients whose anaplastic astrocytoma has recurred or progressed after radiation and temozolomide chemotherapy.

Men and women aged ≥18 years who completed external beam radiation therapy at least 6 months before randomization and who had a Karnofsky performance status of >70 may be eligible for enrollment if other criteria are met. Eligible patients will receive eflornithine plus lomustine or lomustine monotherapy.

The primary outcome measure is overall survival. The secondary outcome measures include progression-free survival and objective response rate. This study plans to enroll 280 patients at multiple locations across the United States and abroad. For more information, contact Marietta Franco, MS, at 650-450-6634 or marietta.franco@orbustherapeutics.com, or Kathleen Villamejor, BS, at 650-656-9424 or kathleen.villamejor@orbustherapeutics.com. The NLM Identifier is NCT02796261.

8 Marizomib plus Bevacizumab and Marizomib Monotherapy for Grade IV Glioblastoma Multiforme

The purpose of this single-group assignment, open-label, phase 1/2 clinical trial is to evaluate a new combination of drugs, marizomib and bevacizumab, for the treatment of grade IV malignant glioma. Phase 1 evaluates the combination of marizomib and bevacizumab, whereas phase 2 evaluates single-agent marizomib.

Men and women aged ≥18 years who had not previously received marizomib or any other proteasome inhibitor or antiangiogenic agent may be eligible for enrollment if other criteria are met. Eligible patients will receive marizomib plus bevacizumab in phase 1 and marizomib monotherapy in phase 2.

The primary outcome measures in phase 1 are the maximum tolerated dose and the recommended phase 2 dose. The primary outcome measure in phase 2 is marizomib monotherapy tumor activity. The secondary outcome measures in phase 1 are tumor activity, marizomib pharmacokinetics, and proteasome activity in packed whole blood. The secondary outcome measures in phases 1 and 2 are safety and tolerance, neurologic coordination assessment, and quality of life.

This study expects to enroll 66 patients at multiple locations across the United States and Canada. For more information, contact Mohit Trikha, PhD, at 858-295-4343 or mohit.trikha@triphaseco.com. The NLM Identifier is NCT02330562.

9 Sorafenib Tosylate, Valproic Acid, and Sildenafil Citrate for Recurrent High-Grade Glioma

This single-group assignment, phase 2 study examines the efficacy of sorafenib tosylate, valproic acid, and sildenafil citrate in patients with recurrent high-grade glioma. Men and women aged ≥18 years with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met.

Eligible patients will receive sorafenib tosylate, valproic acid, and sildenafil citrate. The primary outcome measure is progression-free survival. The secondary outcome measures are overall best response rate and overall survival.

This study plans to enroll 66 patients at Virginia Commonwealth University. For more information, contact Mary Beth Tombes, NP, at 804-628-1357 or mtombes@vcu.edu, or the Solid Tumor Investigator-Initiated Trials team at 804-628-9238 or masseysiit@vcu.edu. The NLM Identifier is NCT01817751.

10 Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Previously Treated Brain Tumors

The purpose of this open-label, single-group assignment, phase 1/2 clinical trial is to determine the side effects and the best dose of melphalan when given with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate, and to see how well they work in patients with previously treated brain tumors.

Men and women aged 18 to 75 years who had previously received temozolomide and have a Karnofsky performance status of ≥50 may be eligible for enrollment if other criteria are met. Patients will receive etoposide, mannitol, melphalan, carboplatin, and sodium thiosulfate.

The primary outcome measures are the maximum tolerated dose of melphalan, overall survival, progression-free survival, response rate, and the time to best response. The secondary outcome measures include functional outcomes, the incidence of severe neutropenia, and the rates of 2-year progression-free survival.

This study plans to enroll 43 patients in Minnesota and Oregon. For more information, contact Matthew A. Hunt at 612-624-1452 or huntx188@umb.edu, or Edward A. Neuwelt at 503-494-5626 or trials@ohsu.edu. The NLM Identifier is NCT00303849.

11 Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment for Primary or Metastatic Brain Tumors

This phase 2, open-label, single-group assignment study examines the efficacy of magnetic resonance imaging (MRI) using the contrast imaging agent ferumoxytol compared with the standard imaging agent gadolinium in measuring tumors in patients undergoing treatment for brain tumors or other tumors that have spread to the brain. Men and women aged ≥18 years with radiographically suspected, histologically or cytologically confirmed primary brain tumors or brain metastasis who have an ECOG performance status of ≤3 may be eligible for enrollment if other criteria are met. Eligible patients will receive intravenous gadolinium on day 1 and intravenous ferumoxytol nonstoichiometric magnetite on day 2.

The primary outcome measure is the contrast-to-noise ratio in terms of normalized signal intensity changes and the contrast-to-noise ratio in terms of normalized signal intensity changes. The secondary outcome measures are the change in cerebral blood volume measurements, change in tumor microvascularity, presence of iron staining, and relevant dynamic MRI signal intensity changes.

This study expects to enroll 150 patients at the Oregon Health & Science University Knight Cancer Institute. For more information, contact Edward A. Neuwelt at 503-494-5626 or neuwelte@ohsu.edu. The NLM Identifier is NCT00659126.