Adult Clinical Trials

Brain Cancer

If you need additional information about any of the trials listed or would like to inquire about other open trials, please contact 919.684.5301 or visit The Preston Robert Tisch Brain Tumor Center at Duke.

18 trials identified.

In-Vitro Generation and Characterization of Cytotoxic T Lymphocytes (CTL) Using Dendritic Cells From Malignant Glioma Patients Pulsed with RNA
Phase: Pilot / Feasibility
Sponsor: PI initiated
Principal Investigator: Gordana Vlahovic
Contact: Robert Preston Tisch Brain Tumor Center
Phone: 919.684.5301
Reference Number: 00009403

Primary and Recurrent Glioma Registry (PRoGREss)
Phase: N/A
Sponsor: PI initiated
Principal Investigator: Annick Desjardins
Contact: Brain Tumor Center at Duke
Phone: 919.684.5301
Reference Number: 00027120

Dose-finding and Safety Study of PVSRIPO Against Recurrent WHO Grade IV Malignant Glioma
Phase: Phase I
Sponsor: PI initiated
Principal Investigator: Gordana Vlahovic
Contact: The Preston Robert Tisch Brain Tumor Center at Duke
Phone: 919.684.5301
Purpose: Purpose of the Study: To determine the maximally tolerated dose (MTD) or the Phase II dose of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED). To obtain correlative mechanistic evidence of PVSRIPO's effects on infected WHO Grade IV malignant glioma tumors and to estimate progression-free survival (PFS) and overall survival (OS) in recurrent WHO Grade IV malignant glioma patients. To obtain information about clinical response rates to intratumoral inoculation of PVSRIPO. To estimate the efficacy of PVSRIPO administered at the optimal dose.
Reference Number: 00031169
View this trial at ClinicalTrials.gov

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
Phase: Phase II
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Mary Affronti
Contact: Robert Preston Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: The objectives of the study are: 1) Primary: Assess CINV efficacy of Aprepitant in combination with Ondansetron vs. Ondansetron alone in preventing acute and delayed CINV (Complete Control (CC): days 1-7) in brain tumor patients during adjuvant temozolomide therapy; and 2) Secondary: To assess the efficacy of Aprepitant in combination with Ondansetron vs Ondansetron alone in preventing acute CINV in brain tumor patients during the acute period (first 24 hours) of receiving adjuvant temozolomide therapy; 3)Secondary: To assess the efficacy of Aprepitant in combination with Ondansetron vs. Ondansetron alone in preventing delayed CINV (days 2-7); 4) Secondary: To assess the safety and tolerability of Aprepitant administered concomitantly with Ondansetron; 5) Exploratory: To assess the time to treatment failure of Ondansetron treatment with and without Aprepitant; 6) Exploratory: To explore the effects of age, gender, chemotherapy history, and concomitant glucocorticoid on the efficacy of Ondansetron treatment with and without Aprepitant; 7) Exploratory: To explore the impact of Aprepitant on quality of life and daily function.
Reference Number: 00031206
View this trial at ClinicalTrials.gov

PERFORMANCE: Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens
Phase: Phase I
Sponsor: PI initiated
Principal Investigator: Gordana Vlahovic
Contact: Robert Preston Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation. Patients will then be randomized to one of three arms: 1). standard temozolomide (TMZ)(200mg/m^2 for 5 days) with vaccine on day 6-8 of each monthly TMZ cycle. 2). standard TMZ (200mg/m^2 for 5 days) with vaccine on day 22-24 of each monthly TMZ cycle. 3). dose-intensified TMZ (100 mg./m^2 for 21 days) with vaccine on day 22-24 of each monthly cycle. All vaccines will be given intradermally (i.d.) and will be given with monthly TMZ cycles and continue after TMZ cycles until progression or death.
Reference Number: 00034208
View this trial at ClinicalTrials.gov

Phase I Single-Center, Dose Escalation Study of D2C7-IT Administered Intratumorally via Convection-Enhanced Delivery for Adult Patients with Recurrent Malignant Glioma
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Dina Randazzo
Contact: Preston Robert Tisch Cancer Research Center
Phone: 919.684.5301
Purpose: This is a Phase I study to determine the maximum tolerated dose (MTD) of D2C7-IT (D2C7 Immunotoxin) when delivered intratumorally by convection-enhanced delivery (CED) to recurrent World Health Organization (WHO) grade III (dose escalation only) and IV (dose escalation and dose expansion) malignant glioma patients, and to determine what dose will be considered in a single-arm Phase II trial. Patients with recurrent WHO grade III (dose escalation only) and IV (dose escalation and dose expansion) malignant glioma who meet eligibility criteria will be enrolled into the study. Immediately following stereotactically-guided tumor biopsy, subjects will have catheters inserted. If the frozen section of the biopsy indicates a proven diagnosis of recurrent malignant glioma (diagnosis results are typically received within 24-48 hours following biopsy), the investigators will proceed with the D2C7-IT infusion. If not, the catheters will be removed. A continuous intratumoral infusion of D2C7-IT will be administered and the same total flow rate for all catheters will be set at 0.5 ml/hour per catheter for 72 hours.
Reference Number: 00053325
View this trial at ClinicalTrials.gov

Evaluation of overcoming Limited migration and Enhancing cytomegalovirus-specific dendritic cell Vaccines with Adjuvant TEtanus pre-conditioning in patients with newly-diagnosed glioblastoma
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Gordana Vlahovic
Contact: Robert Preston Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: This randomized phase II study will assess the impact of pre-conditioning on migration and survival among newly diagnosed glioblastoma (GBM) patients who have undergone definitive resection and completed standard temozolomide (TMZ) and radiation treatment, as well as the impact of tetanus pre-conditioning and basiliximab together on survival. After completing standard of care radiotherapy with concurrent TMZ, patients will be randomized to 1 of 3 treatment arms: 1). receive cytomegalovirus (CMV)-specific dendritic cell (DC) vaccines with unpulsed (not loaded) DC pre-coinditioning prior to the 4th vaccine; 2). receive CMV-specific DC vaccines with Tetanus-Diphtheria Toxoid (Td) pre-conditioning prior to the 4th vaccine; 3). receive basiliximab infusions prior to the 1st and 2nd DC vaccines along with Td pre-conditioning prior to the 4th vaccine. A permuted block randomization algorithm using a 1:1:1 allocation ratio will be used to assign patients to a treatment arm. Randomization will be stratified by CMV status (positive, negative), with the assignment to arms I and II being double-blinded.
Reference Number: 00054740
View this trial at ClinicalTrials.gov

RESIST: Patients with IDH1 Positive Recurrent Grade II Glioma Enrolled in a Phase I Safety and Immunogenicity Study of Tumor-Specific Peptide Vaccine
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Gordana Vlahovic
Contact: Preston Robert Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive testing from the primary tumor (initial diagnosis) will be offered this treatment study in order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy (temozolomide).
Reference Number: 00054746
View this trial at ClinicalTrials.gov

A Feasibility Study to Evaluate the Efficacy and Safety of Perampanel in Seizure Patients with Primary Glial Brain Tumors
Phase: Phase IV
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Katherine Peters
Contact: Preston Robert Tisch Cancer Research Center
Phone: 919.684.5301
Purpose: This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose can be modified by the physician based on patient reported tolerability. Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24 weeks. Assessments will include history and physical examination (H&P) including Karnofsky Performance Status (KPS), neurological examination, evaluation of seizure history, patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of 16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking 6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel. Patients will be considered off treatment at the end of week 20, once perampanel has cleared their system. Patients will then be monitored through Week 24. Patients will continue to take their original AED regimen after they stop perampanel. If seizure control is achieved during the maintenance period or if seizures occur during the tapering period, patients can be continued on perampanel per the discretion of the treating physician. In this instance, perampanel will be prescribed by the treating physician and not provided within the confines of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will be given a log to record the number of seizures that occur. Research team members will regularly contact patients for reminders and reports from the log. Safety will be assessed with the following laboratory evaluations: complete blood count (CBC) with differential, complete metabolic panel (CMP), and toxicity assessment.
Reference Number: 00055609
View this trial at ClinicalTrials.gov

A Phase 1, Multicenter, Open-label, Dose-escalation, Combination Study of Marizomib and Bevacizumab in Bevacizumab-naive Subjects with WHO Grade IV Malignant Glioma Followed by a Phase 2 Trial of Single Agent Marizomib.
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Annick Desjardins
Contact: Preston Robert Tisch Cancer Research Center
Phone: 919.684.5301
Purpose: This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ) and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma. The study population includes subjects who are in first or second relapse and who have not previously received any bevacizumab or other anti-angiogenic agent or proteasome inhibitor for treatment of malignant glioma. Phase 1 evaluates the combination of MRZ and BEV, while Phase 2 evaluates single-agent MRZ.
Reference Number: 00059540
View this trial at ClinicalTrials.gov

A Phase 1/2 Trial for Patients with Newly Diagnosed High Grade Glioma Treated with Concurrent Radiation Therapy, Temozolomide, and BMX-001 (BioMimetix study # BMX-HGG-001)
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Katherine Peters
Contact: Robert Preston Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: This is a Phase 1/2 study of newly diagnosed patients with high grade glioma (HGG) undergoing standard radiation therapy and temozolomide treatment. BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against deterioration of cognition and impairment of quality of life. In Phase 1 safety and tolerability of BMX-001 will be assessed using a two-stage Continual Reassessment Method (CRM). BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. In Phase 2 both safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be assessed. Twenty-four patients will be randomized to the treatment arm that will receive BMX-001 while undergoing chemoradiation and 24 patients randomized to receive chemoradiation alone. The investigators hypothesize that BMX-001 when added to standard radiation therapy and temozolomide will be safe at pharmacologically relevant doses in patients with newly diagnosed high grade glioma. The investigators also hypothesize that in Phase 2 of this study, the addition of BMX-001 will positively impact the overall survival and improve objective measures of cognition in newly diagnosed high grade glioma patients.
Reference Number: 00062660
View this trial at ClinicalTrials.gov

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
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Katherine Peters
Contact: Preston Robert Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in Gliomas, that harbor an IDH1 and/or IDH2 mutation.
Reference Number: 00063389
View this trial at ClinicalTrials.gov

Phase 2 Study of Sym004 for Adult Patients with Recurrent Glioblastoma
Phase: Phase II
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Annick Desjardins
Contact: Preston Robert Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: The purpose of this study is to assess the activity of Sym004, a recombinant antibody mixture that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma whose tumor is EGFR amplified. This is a phase 2 study that will accrue a total of 61 patients with WHO grade IV recurrent malignant glioma (glioblastoma or gliosarcoma) in two cohorts to assess the efficacy of Sym004.
Reference Number: 00063483
View this trial at ClinicalTrials.gov

Anti-PD-1 monoclonal antibody (nivolumab) in combination with DC Vaccines for the Treatment of Recurrent Grade III and Grade IV Brain Tumors
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Gordana Vlahovic
Contact: Robert Preston Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab alone and with DC vaccine therapy until surgical resection. During surgical resection blood and tumor samples will be assessed and compared. Following surgery, both groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.
Reference Number: 00065241
View this trial at ClinicalTrials.gov

A Randomized Phase 2 Single Blind Study of Temozolomide plus Radiation Therapy combined with Nivolumab or Placebo in Newly Diagnosed Adult Subjects with MGMT-Methylated (tumor 06-methylguanine DNA methyltranferase) Glioblastoma (BMS CA209-548)
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Gordana Vlahovic
Contact: Preston Robert Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: The main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live after receiving temozolomide plus radiation therapy compared with patients receiving nivolumab in addition to temozolomide plus radiation therapy.
Reference Number: 00071737
View this trial at ClinicalTrials.gov

A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06840003 IN PATIENTS WITH MALIGNANT GLIOMAS
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Gordana Vlahovic
Contact: Robert Preston Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in patients with malignant gliomas.
Reference Number: 00073139
View this trial at ClinicalTrials.gov

Phase 1b, Multicenter, Open-label Study of Marizomib Combined with Temozolomide and Radiotherapy in Patients with Newly Diagnosed WHO Grade IV Malignant Glioma. (Triphase MRZ-112)
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Annick Desjardins
Contact: Robert Preston Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: This study is for newly diagnosed WHO Grade IV malignant glioma patients to determine whether an investigational drug known as marizomib (MRZ) will improve the treatment of newly diagnosed glioblastoma patients by delaying the growth of the cancer, reducing the size of the tumor, and/or improving survival.
Reference Number: 00076670
View this trial at ClinicalTrials.gov

A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Annick Desjardins
Contact: Preston Robert Tisch Brain Tumor Center
Phone: 919.684.5301
Purpose: The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
Reference Number: 00076758
View this trial at ClinicalTrials.gov