Clinical trials help bring hope, advance treatments, and often improve prognosis. Trials can be especially helpful for patients who have had a tumor come back, and the tumor is known to be aggressive and not responsive to current treatments.

Clinical trials are scientific studies in which new treatments are tested in patients to determine if they are safe and effective. Johns Hopkins has a long history of collaboration between basic scientists and clinical scientists, who advance new ideas from the laboratory to patients. We believe that well-designed and carefully conducted research will lead us to the next major breakthrough in the treatment of patients with malignant brain tumors.

To qualify for a clinical trial, participants must meet carefully defined criteria. Please contact the study nurse for the trial you are interested in to see if you qualify and if there are open spots in the trial. You may also email our study nurses if you are unsure which trial is right for you.

Trials for Patients Who've Been Diagnosed with a Brain Tumor for the First Time

A Phase 2 Master Protocol to assess the efficacy and safety of FORE8394, an inhibitor of BRAF class 1 and class 2 alterations, in participants with cancer harboring BRAF alterations (J22112)

Contact: Michaella Iacoboni, RN (410-955-4009 or [email protected])
Principal Investigator: Dr. Karisa Schreck
Objective: The objective of this master protocol is to enable the conduct of the subprotocols. The efficacy, safety, pharmacokinetics, and pharmacodynamics of FORE8394 in defined subgroups of participants with tumors harboring BRAF alterations will be evaluated in participants enrolled to each subprotocol.
Eligibility Criteria: Participants aged 10 years or older who have an eligible tumor harboring a BRAF abnormality and who provide informed consent will be eligible for a given subprotocol, if they meet the subprotocol-specific entry criteria
More information on clinicaltrials.gov: NCT05503797

Study of Immunotherapy with Standard Chemoradiation vs. Standard Chemoradiation in Patients with New Glioblastoma who Received Gliadel Wafers (NCT05083754, J21103)

Contact: Kelly Szajna, RN, BSN (410-502-4081 or [email protected])
Principal Investigator: Dr. Lawrence Kleinberg
Objective: To evaluate retifanlimab, an immunotherapy drug, in adults who have already received Gliadel wafers to treat glioblastoma multiforme.
Eligibility Criteria: Adults with glioblastoma (GBM) that received Gliadel at the time of surgery
More information on clinicaltrials.gov: NCT05083754

Study of Subventricular Zone (SVZ) Irradiation+TMZ in New Glioblastoma (IRB00031466, J1426)

Contact: Kristin Redmond, MD (410-614-1642 or [email protected]) or Aliya Laliji ([email protected]) for Sibley location
Principal Investigator: Dr. Kristin Redmond
Objective: To see if an investigational method of giving radiation to adults with glioblastoma multiforme (GBM) can improve the local control and increase the time it may take for your brain cancer from coming back.
Eligibility Criteria: Adults with glioblastoma (GBM)
More information on clinicaltrials.gov: NCT02177578

Study of Radiotherapy with Temozololide vs Radiotherapy with PCV Chemotherapy Anaplastic Glioma or Low-Grade Glioma (NCTNA0577, NA_00093264)

Contact: Phase1 Clinical Trials ([email protected]) and Jeannette Smith ([email protected])
Principal Investigator: Dr. Matthias Holdhoff
Objective: To compare standard chemoradiation with radiotherapy followed by PCV chemotherapy [PCV chemotherapy consists of three drugs, Matulane (procarbazine), Lomustine (CCNU) and Oncovin (vincristine)] in of anaplastic glioma or low-grade glioma
Eligibility Criteria: Adults with Anaplastic Glioma or Low Grade Glioma with the 1p/19q co-deletion and IDH tumor markers
More information on clinicaltrials.gov: NCT00887146

Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas (NCT05768919, J2265)

Contact: Michaella Iacoboni, RN, BSN (410-955-4009 or [email protected])
Principal Investigator: Dr. Matthias Holdhoff
Objective: The objective of this study is to assess the tolerability, safety and efficacy of liposomal curcumin (LC) in combination with radiotherapy (RT) and Temozolomide (TMZ) in patients with newly diagnosed high-grade gliomas (HGG).
Eligibility Criteria: Adults with glioblastoma (GBM) planning standard therapy with TMZ and RT for 6 weeks
More information on clinicaltrials.gov: NCT05768919

Trials for Patients Whose Brain Tumor Returned After Treatment

A Study of the Treatment of Recurrent Malignant Glioma With rQNestin (J2309, IRB00367511)

Contact: Kelly Szajna, RN, BSN (410-502-4081 or [email protected])
Principal Investigator: Dr. Chetan Bettegowda
Objective: This research is being done to test if an investigational study drug called rQNestin34.5v.2 is safe to use in humans, when given in up to six repeated doses, and if it is effective in treating malignant glioma
Eligibility Criteria: Adults with recurrent or residual grade 4 glioblastoma (GBM), grade 3 anaplastic astrocytoma or oligodendroglioma, or grade 2 astrocytoma with features consistent with GBM may join the study.
More information on clinicaltrials.gov: NCT03152318

A Phase 2 Master Protocol to assess the efficacy and safety of FORE8394, an inhibitor of BRAF class 1 and class 2 alterations, in participants with cancer harboring BRAF alterations (J22112)

Contact: Michaella Iacoboni, RN (410-955-4009 or [email protected])
Principal Investigator: Dr. Karisa Schreck
Objective: The objective of this master protocol is to enable the conduct of the subprotocols. The efficacy, safety, pharmacokinetics, and pharmacodynamics of FORE8394 in defined subgroups of participants with tumors harboring BRAF alterations will be evaluated in participants enrolled to each subprotocol.
Eligibility Criteria: Participants aged 10 years or older who have an eligible tumor harboring a BRAF abnormality and who provide informed consent will be eligible for a given subprotocol, if they meet the subprotocol-specific entry criteria
More information on clinicaltrials.gov: NCT05503797

Study of [177Lu]-NeoB advanced solid tumors (including brain) that overexpress GRPR (gastrin-releasing peptide receptor) (IRB00204950, J1924)

Contact: Avery Spitz, RN (443-253-3894 or [email protected])
Principal Investigator: Lilja Solnes
Objective: To see if the investigational product (NeoB) can be used safely to help
diagnose and treat advanced solid tumors.
Eligibility Criteria: People with advanced solid tumors, including brain tumors
More information on clinicaltrials.gov: NCT03872778 

Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas (IRB00102683, A071401)

Contact: Phase1 Clinical Trials ([email protected]) and Jeannette Smith ([email protected])
Principal Investigator: Dr. Chetan Bettegowda
Objective: This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria: People with progressive or recurrent meningioma may be eligible for this study.
More information on clinicaltrials.gov: NCT02523014

Observational Studies and Supportive Care

Unlike clinical trials, observational studies are designed to observe rather than treat. In an observational study, researchers may evaluate changes in symptoms, results or side effects of a treatment, or how well different diagnostic methods detect or monitor brain tumors. For example, researchers may ask observational study participants to undergo an imaging test, such as MRI or PET scan to learn about diagnosing brain tumors from imaging. Both patients with brain tumors and healthy volunteers can participate in observational studies.

Temporary Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Suspected Glioblastoma (IRB00327491, J2238)

Contact: Kelly Szajna, RN, BSN (410-502-4081 or [email protected])
Principal Investigator: Dr. Jordina Rincon-Torroella
Objective: To test a new procedure to disrupt the blood brain barrier (Exablate BBBD with MRgFUS, or MR-guided focused ultrasound) and see what effects (good and bad) it has on the biomarkers released into the bloodstream.
Eligibility Criteria: Adults scheduled for brain tumor surgery

An MRI study for patients receiving high-dose methotrexate (IRB00237563, J2029)

Contact: Michaella Iacoboni, RN (410-955-4009 or [email protected])
Principal and Co-Investigator: Dr. David Kamson and Dr. Stuart Grossman
Objective: To assess the feasibility to non-invasively detect and quantify chemotherapy drug concentrations using an MRI.
Eligibility Criteria: Patients with tumors already being treated with high-dose methotrexate chemotherapy

Protein and metabolite mapping of human muscle and brain by MRI (IRB00283785)

Contact: Contact: Jiadi Xu (410-598-0920 or [email protected])
Principal Investigator: Jiadi Xu
Objective: To examine the protein profile and metabolites changes after the chemotherapy using a non-invasive MRI method.
Eligibility Criteria: Healthy volunteers ages 18-80
More information on clinicaltrials.gov: NCT04234880

Human brain protein MR imaging and spectroscopy (NA_00034512, J0578)

Contact: Lindsay Blair ([email protected])
Principal and Co-Investigator: Jinyuan Zhou / Shanshan Jiang
Objective: To develop and refine a novel protein-based MRI technique, called amide proton transfer (APT) imaging, to better assess the status of disease in patients with brain tumors.
Eligibility Criteria: Known or suspected primary malignant brain tumors and healthy volunteers

Resource for quantitative functional MRI (IRB00036313)

Contact: Georg Oeltzschner ([email protected]) and Lindsay Blair ([email protected])
Principal and Co-Investigator: Georg Oeltzschner
Objective: To develop and evaluate advanced spectral-edited magnetic resonance spectroscopic biomarkers of IDH and 1p/19q codelection in brain tumors

Development and translation of D-glucose as a diagnostic agent for MRI of cancer (NA_00049677)

Contact: Nirbhay Yadav ([email protected]) or Lindsay Blair ([email protected])
Principal and Co-Investigator: Peter van Zijl / Nirbhay Yadav
Objective: To develop and translate to the clinic the use of D-glucose as an intravenous MRI contrast agent for the combined imaging of tumor perfusion, permeability, and metabolism.
Eligibility Criteria: Brain mass consistent with a primary brain tumor or metastatic brain tumor and healthy volunteers