Brain Tumor Clinical Trials
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.
Explore Open Clinical Trials
Trials for Patients Who've Been Diagnosed with a Brain Tumor for the First Time
A Target Validation/Phase1 Study of BGB-290 in Combination with Temozolomide in Adolescent and Young Adult IDH1/2 Newly Diagnosed and Recurrent Mutant Gliomas (PNOC017) (J1950)
Contact: Kenneth Seidl, research nurse ([email protected])
Principal Investigator: Dr. Kenneth Cohen
Objective: Determine the safety and tolerability of the combination of pamiparib (BGB-290) and temozolomide (TMZ) in AYA subjects with IDH1/2-mutant glioma, including the maximum tolerated dose (MTD) and characterization of dose-limiting toxicities (DLTs) in both, newly diagnosed and recurrent treatment arms
Eligibility Criteria: Patients up to 39 y/o with either a newly diagnosed or recurrent IDH1/2 mutant gliomas (any grade)
More information: NCT03749187
A Combination Therapy Trial using an Adaptive Platform Design for Children and Young Adults with Diffuse Midline Gliomas (DMGs) including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression (PNOC022) (J2223 )
Contact: Kenneth Seidl, research nurse ([email protected])
Principal Investigator: Dr. Kenneth Cohen
Objective: Information dependent on cohort assignment
Eligibility Criteria: Patients up to 39 y/o with a newly diagnosed or recurrent Diffuse Midline Glioma(DMG) including Diffuse Intrinsic Pontine Glioma( DIPG)
More information: NCT05009992
Nivolumab and DAY101 for the Treatment of Newly Diagnosed or Recurrent Craniopharyngioma in Children and Young Adults (J23103)
Contact: Kenneth Seidl, research nurse ([email protected])
Principal Investigator: Dr. Kenneth Cohen
Objective: The purpose of this study is to determine if the combination of tovorafenib and nivolumab is effective for treating patients with craniopharyngioma while maintaining the patient’s quality of life
Eligibility Criteria: Participants up to age of 39 y/o with a newly diagnosed or recurrent craniopharyngioma
More information: NCT05465174
A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas (PACNS2321 - ACNS2321)
Contact: Kenneth Seidl, research nurse ([email protected])
Principal Investigator: Dr. Kenneth Cohen
Objective: The purpose of this study is to see if this approach is better or worse than the usual approach for your germinoma tumor. The usual approach is defined as care most people get for germinoma tumor.
Eligibility Criteria: Participants up to age of 30 y/o with a newly diagnosed (by pathology) germinoma
More information: NCT06368817
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: Fredo Guastella ([email protected]) or Michaella Iacoboni, RN ([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 (667-306-8142 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 from Johns Hopkins
More information on clinicaltrials.gov: NCT05083754
Trials for Patients Whose Brain Tumor Returned After Treatment
Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma (A072201)
Contact: Developmental Therapeutics ([email protected])
Principal Investigator: Solmaz Sahebjam, M.D.
Objective: The purpose of this study is to evaluate the efficacy of combining BMS-986016 (relatlimab) and nivolumab in recurrent GBM vs. SOC CCNU (Lomustine).
Eligibility Criteria: People with progressive or recurrent glioblastoma multiforme without IDH mutation (IDH1 R132H negative by IHC or sequencing) who are in first recurrence of glioblastoma after radiation therapy and temozolomide.
More information: NCT06325683
A Target Validation/Phase1 Study of BGB-290 in Combination with Temozolomide in Adolescent and Young Adult IDH1/2 Newly Diagnosed and Recurrent Mutant Gliomas (PNOC017) (J1950)
Contact: Kenneth Seidl, research nurse ([email protected])
Principal Investigator: Dr. Kenneth Cohen
Objective: Determine the safety and tolerability of the combination of pamiparib (BGB-290) and temozolomide (TMZ) in AYA subjects with IDH1/2-mutant glioma, including the maximum tolerated dose (MTD) and characterization of dose-limiting toxicities (DLTs) in both, newly diagnosed and recurrent treatment arms
Eligibility Criteria: Patients up to 39 y/o with either a newly diagnosed or recurrent IDH1/2 mutant gliomas (any grade)
More information: NCT03749187
A Phase 1 Study of Intra-Tumoral Injections of Ex Vivo Expanded Natural Killer Cells in Children and Young Adults with Recurrent or Progressive Malignant Brain Tumors (PNOC028)
Contact: Kenneth Seidl, research nurse ([email protected])
Principal Investigator: Dr. Kenneth Cohen
Objective: The purpose of this study is to see if it is safe and feasible to treat brain tumors with donor natural killer (NK) cells. The cells will be administered directly into the tumor or the resection area using a device called an Ommaya reservoir.
Eligibility Criteria: Participants up to age of 39 y/o that have a recurrent or progressive malignant brain tumor including, but not limited to, infant-type hemispheric glioma, gliosarcoma, intracranial sarcoma and WHO Grade II ependymoma
More information: NCT05887882
Nivolumab and DAY101 for the Treatment of Newly Diagnosed or Recurrent Craniopharyngioma in Children and Young Adults (J23103)
Contact: Kenneth Seidl, research nurse ([email protected])
Principal Investigator: Dr. Kenneth Cohen
Objective: The purpose of this study is to determine if the combination of tovorafenib and nivolumab is effective for treating patients with craniopharyngioma while maintaining the patient’s quality of life
Eligibility Criteria: Participants up to age of 39 y/o with a newly diagnosed or recurrent craniopharyngioma
More information: NCT05465174
A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor (ACNS2021)
Contact: Kenneth Seidl, research nurse ([email protected])
Principal Investigator: Dr. Kenneth Cohen
Objective: The purpose of this study is to see if radiation therapy (RT) to the spine and a portion of the brain works just as well as the standard treatment, which includes RT to the whole brain and spine, for people with NGGCT who agree to take part in this study and whose disease responds well to induction chemotherapy, or who have no signs of disease following surgery. Also, to see if we can lower the number of relapses in the spine for subjects who receive RT to the spine and a portion of the brain only, as compared to subjects on previous studies who received radiation to a portion of the brain only and none to the spine.
Eligibility Criteria: Participants up to age of 30 y/o with a diagnosis of a brain cancer called non-germinomatous germ cell tumor (NGGCT)
More information: NCT04684368
Feasibility of CSF and Plasma ctDNA in BRAF-altered Glioma During Treatment With Plixorafenib (J2488)
Contact: Fredo Guastella ([email protected]) or Michaella Iacoboni, RN ([email protected])
Principal Investigator: Dr. Karisa Schreck
Objective: This study is being done to see if circulating tumor DNA (ctDNA) measured in blood and cerebrospinal fluid (CSF) before and after one month of administration of the investigational BRAF inhibitor plixorafenib can provide useful information about the status of your tumor. The study will also evaluate the activity of this drug for adults whose tumors have an alteration in the BRAF gene and who have already been treated with BRAF and/or MEK inhibitors.
Eligibility Criteria: People 18 years or older with recurrent/progressive BRAF-V600E mutant glioma who have previously received BRAF and/or MEK inhibitor therapy and have a clinically planned surgery may join.
More information on clinicaltrials.gov: NCT06610682
A Study of the Treatment of Recurrent Malignant Glioma With rQNestin (J2309, IRB00367511)
Contact: Kelly Szajna, RN, BSN (667-306-8142 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: Fredo Guastella ([email protected]) or Michaella Iacoboni, RN ([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
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 (667-306-8142 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
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 Roche, 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: Dory Roche, lead research nurse ([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
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.
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: Fredo Guastella ([email protected]) or Michaella Iacoboni, RN ([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