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 fill out this form 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 Radiotherapy with Temozolomide 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

Phase IIA Trial of Dichloroacetate in Glioblastoma Multiforme (IRB00300857, J2189)

Contact: Michaella Iacoboni, RN ([email protected]) and Erin Dailey, RN ([email protected])
Principal Investigator: Dr. Stuart Grossman
Objective: This research is being done to determine if the a drug called sodium dichloroacetate (DCA), which is an investigational drug not approved by the FDA, can change the chemical reactions that help make GBM tumors grow.
Eligibility Criteria: Adults with recurrent or residual grade 4 glioblastoma (GBM) who will undergo standard of care surgery
More information on clinicaltrials.gov: NCT05120284 

A Phase 1A Dose Escalation Study of LP-184 in Patients with Advanced or Metastatic Solid Tumors (LTRN184-1AST23-1, IRB00403221, J23141)

Contact: Phase 1 group ([email protected]) and Christina Raynor ([email protected])
Principal Investigator: Dr. Karisa Schreck
Objective: This research is being done to learn more about the safety and effects of the investigational drug LP-184 when given to people with advanced solid cancer
Eligibility Criteria: Adults that have a histologically or cytologically documented advanced solid tumor that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.
More information on clinicaltrials.gov: NCT05933265

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 

A Phase 1, Safety Lead-In and Randomized, Open-label, Perioperative Study of Vorasidenib in Combination with Pembrolizumab in Subjects with Recurrent or Progressive Enhancing IDH-1 Mutant Glioma (IRB00435612, J2457)

Contact: Michaella Iacoboni, RN (410-955-4009 or [email protected])
Principal Investigator: Dr. Matthias Holdhoff
Objective: The primary objective of the study is to evaluate T-cell infiltration in tumor tissue following neoadjuvant treatment with vorasidenib in combination with pembrolizumab.
Eligibility Criteria: Adults with Grade 2 or 3 Glioma with IDH-R132H gene mutation with recurrent or progressive disease following one prior treatment who a surgical intervention is appropriate.
More information on clinicaltrials.gov: NCT05484622

SONOBIRD: Sonocloud-9 in Association With Carboplatin Vs Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM (J23149, IRB00415213)

Contact: Kelly Szajna, RN, BSN (410-502-4081 or [email protected])
Principal Investigator: Dr. Chetan Bettegowda
Objective: The goal of the research study is to learn if the SonoCloud-9 (SC9) implantable device can be used in combination with Carboplatin chemotherapy to help control glioblastoma (a brain tumor) at the time of recurrence.
Eligibility Criteria: Adults with recurrent GBM being referred for surgery.
More information on clinicaltrials.gov: NCT05902169

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

Trials for People with Other Cancers or Cancers that Have Spread to the Brain

Preservation of Cognition and Neuropsychiatric Functioning with Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study (IRB00128471, J1737)

Contact: Dory Smith, Lead Research Nurse ([email protected])
Principal Investigator: Dr. Kristin Redmond
Objective: Primary-Evaluate changes in cognition from baseline to 4 months following genu-sparing whole brain radiation therapy (GS-WBRT)
Eligibility Criteria: Solid tumor brain metastases receiving WBRT, Karnofsky Performance Status  ≥60, Brain MRI within 1 month of enrollment, MMSE ≥24
More information on clinicaltrails.gov: NCT03223922

Exploration of Personalized Biomarkers during Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma (IRB00291203, J2317)

Contact: Shirl Dipasquale, Lead Research Nurse Manager ([email protected])
Principal Investigator: Dr. Kristin Redmond
Objective: To characterize the value of combining changes in ctDNA with 
radiomic predicting histopathologic findings
Eligibility Criteria: Histologically proven chordoma of the spine or sacrum, radiographic evidence of spinal sacral chordoma confirmed by CT or MRI, SBRT is appropriate treatment for the chordoma, Karnofsky Performance Score of 40 or greater.
More information on clinicaltrails.gov: NCT06463262

A Pilot Study of Stereotactic Radiosurgical Hypophysectomy for Intractable Pain from Bone Metastases (IRB00158648, J17181)

Contact: Dory Smith, Lead Research Nurse ([email protected])
Principal Investigator: Dr. Kristin Redmond
Objective: Assessing whether delivery of a single high dose of radiation therapy to a small area of the pituitary gland and pituitary stalk in a highly precise manner may be helpful in reducing intractable pain from bone metastases.
Eligibility Criteria: Histologically proven malignancy, radiographic evidence of bone metastases on CT, MRI, and/or bone scan, intractable pain uncontrolled by medical management, diffuse osseous pain not targetable by conventional radiation therapy, progressive malignancy not amenable to curative management
More information on clinicaltrails.gov: NCT03377517

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

Cognitive outcomes after brain substructure-informed radiation planning in pediatric patients (CogRT) (J2255)

Contact: Shruti Agarwal, Sr. Research Program Coordinator ([email protected])
Principal Investigator: Sahaja Acharya, M.D.
Objective: To determine the feasibility of substructure-informed radiation planning for pediatric patients undergoing radiation therapy. Feasibility will be achieved if 70% meet certain dose constraints and these dose constraints will differ based on radiation fields.
Eligibility Criteria: Children and adults aged 1 to <26 years of age with brain tumors
Stratum A: Patients must not have started radiation therapy. 
Stratum B: Patients diagnosed with a brain tumor at <26 years of age who received radiation therapy less than 2 years ago and the cancer has not come back
Stratum C: Patients must be aged 5 to <26 years of age and able to complete research imaging without sedation
More information on clinicaltrails.gov: NCT05658731

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