Behavioral Neurology Trials

As part of an academic medical center, the Division of Behavioral Neurology at Northwestern University Feinberg School of Medicine aims to improve human health through scientific research. Clinical trials test or study drugs, surgical procedures, medical devices or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

The following searchable list includes all the behavioral neurology clinical trials currently looking for participants.

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NUDB 13C03: Northwestern Brain Tumor Institute Research Database The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it … The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information. The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies. Eligibility Criteria You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB. Principal Investigator Kumthekar, Priya U Location(s) Map it 201 E. Huron St. Chicago, IL IRB number STU00087359 More Info Email Study Coordinator Phone 1 312 695 1102 Copy Study URL to Clipboard Copy
A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Overview Bevacizumab (the study drug) is considered investigational because the US Food and Drug Administration (FDA) has not … Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Overview Bevacizumab (the study drug) is considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study drug is a medication that blocks the growth of new blood vessels. In order for tumors to grow they need to have a blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Optune (the study device) is also considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study device, Optune is a device that the patient will wear and use for at least 18 hours of each day. It delivers alternating electrical current to the patient‰Ûªs brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to occur in order for cell division to occur and allows tumors to grow. By slowing this process, we hypothesize that meningioma growth may also be slowed. Description of Treatment Tumor treatment field therapy with Optune will be initiated at the same time as bevacizumab, with both treatments to start within a one-week period of each other. Bevacizumab will be given at current standard central nervous system (CNS) dosing of 10mg/kg q2 weeks in an outpatient setting. After 4 cycles (1 cycle=28days) of therapy (Cycle 5 day 1) patients may choose to switch to bevacizumab at a dose of 15 mg/kg q3 weeks. For patients who chose to make this switch, they have to do it on Day1 of a new cycle. Tumor treatment fields with Optune will be delivered for at least 18 hours a day at a frequency of 200 KHz and intensity of 1-3V/cm. Treatment will be continued until disease progression or up to 1 year. Eligibility Criteria"Some of the eligibility criteria include: - Patients must be age = 18 years. Both males and females and patients from all ethnic backgrounds are eligible. - Patients must have a histologic diagnosis of meningioma, WHO grade 2 or 3 (atypical or anaplastic). - All patients must have developed recurrent disease/progression after receiving all standard treatments. Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial." Principal Investigator Kumthekar, Priya U Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT02847559IRB number STU00203030 More Info Email Study Coordinator Phone 312 695 1102 Copy Study URL to Clipboard Copy
(xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases … The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your metastatic cancer. The usual approach is defined as care most people get for your metastatic cancer. Eligibility Criteria Participantsmust be 18 years or older Participants must have a confirmed diagnosis of cancermetastasized to the brain Principal Investigator Kumthekar, Priya U Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03994796IRB number STU00211229 More Info Keywords Metastatic brain tumors Email Study Coordinator Phone 312 695 1102 Copy Study URL to Clipboard Copy
Phase 1/2 trial of blood-brain barrier opening with the SonoCloud-9 implantable ultrasound device and treatment with albumin-bound paclitaxel in patients with recurrent glioblastoma Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be … Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients. Eligibility Criteria Inclusion Criteria: Confirmed diagnosis of Isocitrate Dehydrogenase 1 (IDH1) wild-type glioblastoma on pathology from initial surgery (e.g. IDH R132H neg); morphologic or molecular determination of grade 4 Ability to undergo contrast-enhanced MRI Radiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapy Measurable or evaluable disease Measurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRI Non-measurable/evaluable: contrast-enhancement diameters < 1 cm Maximal tumor diameter pre-surgery ≤ 70 mm on T1wMRI Candidate for at least partial surgical resection Greater 12 weeks from completion of radiation therapy Age ≥ 18 years If receiving dexamethasone for mass effect, a stable daily dose of dexamethasone at < 6 mg within 7 days of registration, or if dexamethasone dose is decreasing, average daily dose of < 6 mg in the 7 days prior to registration. Patients on dexamethasone for reasons other than mass effect may still be enrolled. WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70) Adequate hepatic, renal and bone marrow function, documented with normal laboratory values or no more than grade 1 outside the norm performed within 14 days prior to registration For patients with a childbearing potential Negative pregnancy test within 14 days prior to registration Agreement to use adequate contraception for the duration of study participation, and for 3 and 6 months after the last dose of albumin-bound paclitaxel for men and women of childbearing potential, respectively. Have the ability to understand and the willingness to sign a written informed consent prior to registration on study Be willing and able to comply with the protocol for the duration of the study Provide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtained Exclusion Criteria: Have multifocal disease that cannot be encompassed in the ultrasound fields: e.g. > 70-mm apart tumor located in the posterior fossa Patients at risk of cranial wound dehiscence Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics Have clinical evidence of peripheral neuropathy on examination Have received any other investigational agents within 4 weeks of registration Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin Medical contraindications to Abraxane® or carboplatin Have an uncontrolled intercurrent illness Are pregnant or nursing Have a history of active malignancy within 3 years prior to registration. Have a known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Definity® (the FDA-approved ultrasound contrast agent to be used in this study) Patients with coils, clips, shunts, intravascular stents, and/or non-removable wafer, non resorbable dura substitute, or reservoirs. Patients with medical need to continue antiplatelet therapy. Patients with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome (patient at risk for microbubble reaction). Patients with impaired thermo-regulation or temperature sensation (due to device) Principal Investigator Sonabend Worthalter, Adam Mendel Location(s) Map it 675 N. Saint Clair St. Twentieth Floor Chicago, IL ClinicalTrials.gov IdentifierNCT04528680IRB number STU00212298 More Info Keywords brain tumor glioblastoma recurrent glioblastoma GBM Email Gomez, Cristal Guillermina Phone +1 312 926 9912 Copy Study URL to Clipboard Copy

Behavioral Neurology Trials

NUDB 13C03: Northwestern Brain Tumor Institute Research Database

A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma

(xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

Phase 1/2 trial of blood-brain barrier opening with the SonoCloud-9 implantable ultrasound device and treatment with albumin-bound paclitaxel in patients with recurrent glioblastoma