High Grade GliomaPhase 1NCT03971734

Determining Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas

A Phase 1 study testing Regadenoson 0.05mg, Regadensoson 0.1mg and Regadensoson 0.2mg in people with High Grade Glioma and Anaplastic Astrocytoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

enroll patients with histologically confirmed high-grade gliomas to evaluate the ability of regadenoson to transiently disrupt a relatively intact blood-brain barrier (BBB). determine the best dose of regadenoson to disrupt the BBB and allow for enhanced penetration of gadolinium during MRI. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: High Grade Glioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma
What is being tested?: Regadenoson 0.05mg, Regadensoson 0.1mg and Regadensoson 0.2mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 2 sitesUnited States
Study dates: 6 Dec 2019to 2 Oct 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients must have histologically confirmed high grade glioma (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), gliosarcoma, and anaplastic oligodendroglioma). Patients with previous low-grade glioma who progressed after RT/chemotherapy and are biopsied and found to have GBM/GS are eligible.
Patients must have measurable contrast-enhancing disease by MRI imaging within 7-14 days of starting treatment (defined by at least 1 cm x 1 cm). Patient must be able to tolerate MRIs with contrast.
Patients must have stable MRI (no progression of disease) for the past 2 months or more.
Patients may have an unlimited number of prior relapses.
The following intervals from previous treatments are required to be eligible:
12 weeks from the completion of radiation.

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16 weeks from an anti-VEGF therapy
6 weeks from a nitrosourea chemotherapy
3 weeks from a non-nitrosourea chemotherapy
2 weeks or 5 half-lives from any investigational (not FDA-approved) agents
2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)
Age ≥18 years and ≤ 45 years.
Karnofsky Performance (KPS) Status 80% (see Appendix A).
Patients must have adequate organ and marrow function as defined below:
Creatinine ≤ 1.5 mg/Dl or eGFR ≥30 mL/min/1.73 m2
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of regadenoson are eligible for this trial.
Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Patients who are receiving any other investigational agents.
History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to regadenoson.
Patients with any history, current symptoms, or signs of cardiovascular disease including:
any ischemic cardiac event (myocardial infarction, coronary revascularization, stable or unstable angina)
Ischemic or nonischemic cardiomyopathy and/or congestive heart failure

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Supraventricular tachycardia, atrial fibrillation, and/or atrial flutter
Ventricular tachyarrhythmias
Severe sinus bradycardia defined as a resting heart rate <40 bpm
Symptomatic bradycardia, sick sinus syndrome, greater than first-degree AV block, left bundle branch block, and/or presence of a cardiac pacemaker
Stenotic valvular heart disease
Patients who have uncontrolled hypo- or hypertension defined as a systolic blood pressure <90 mmHg or >180 mmHg, respectively.
Patients who have uncontrolled asthma or seizures.
Patients taking potential neurotoxic medications - see eligibility criteria of protocol for specific list of medications
Patients with uncontrolled concurrent illness.
Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women will be excluded from this study.
Because of the potential risk of serious cardiac reactions in the breastfed infant, advise the nursing mother to pump and discard breast milk for 10 hours after administration of regadenoson

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Determining the Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas

Read the detailed description

PRIMARY OBJECTIVE:

To determine if there is a dose of regadenoson, in the range shown to be safe for clinical administration, that can increase gadolinium Ktrans by more than 10 times the values reported in the literature within normal-appearing brain parenchyma with a previously documented intact blood-brain barrier in patients with high grade gliomas.

SECONDARY OBJECTIVE To determine if there is a dose of regadenoson, in the range shown to be safe for clinical administration, that can substantially alter the normalized, contrast enhanced MRI signal intensity in normal-appearing tissues and in: A) Brain adjacent to tumor (i.e. T2 hyperintense, but without contrast enhancement before regadenoson) and B) Contrast enhancing tumor (with contrast enhancement before regadenoson).

Part I Treatment Plan

Part I of the protocol is designed to identify the best regadenoson dose(s) to transiently disrupt the blood-brain barrier as measured by DCE-MRI and contrast enhancement on T1-weighted images corresponding to an increase in the accumulation of MRI contrast (gadolinium) into normal appearing brain contralateral to the brain tumor.

Patients who are at low risk of having complications with a standard regadenoson cardiac stress test (young with no known cardiac disease) and who have had stable MRI scans for at least 2 months prior to enrollment will be asked to undergo a research MRI within two weeks after their most recent previous MRI.

Part II Treatment Plan

Part II will be initiated if the first portion of the study identifies one or more doses of regadenoson that meets the desired endpoint of a Ktrans value >0.04 min-1 within contralateral normal-appearing brain following regadenoson administration. Part II patients will undergo more extensive imaging prior to regadenoson administration to confirm that regadenoson has a significant effect on the BBB using a more comprehensive imaging approach.

Five additional patients who are at low risk to have complications of a standard chemical cardiac stress test (young with no known significant cardiac disease) will be sequentially enrolled at each regadenoson dose meeting the desired endpoint in Part I. In these cohorts, the full research imaging protocol will be utilized in both the pre- and post-regadenoson MRI scans which will allow a direct comparison of all imaging parameters in both the pre-regadenoson and post-regadenoson settings to be directly compared.

Conditions: High Grade Glioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Glioblastoma
Being tested: Regadenoson 0.05mg, Regadensoson 0.1mg, Regadensoson 0.2mg, Regadensoson 0.4mg, Regadensoson 0.7mg
Medical subject headings: Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Regadenoson 0.05mgDrug
Regadensoson 0.05mg administered prior to MRI
Regadensoson 0.1mgDrug
Regadensoson 0.1mg administered prior to MRI
Regadensoson 0.2mgDrug
Regadensoson 0.2mg administered prior to MRI
Regadensoson 0.4mgDrug
Regadensoson 0.4mg administered prior to MRI
Regadensoson 0.7mgDrug
Regadensoson 0.7mg administered prior to MRI
Regadensoson 1.0mgDrug
Regadensoson 1.0mg administered prior to MRI
Regadensoson 1.4mgDrug
Regadensoson 1.4mg administered prior to MRI

Study groups in NCT03971734
Study group	Role	What they receive
Arm 1 regadenoson 0.05mg	Experimental	Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose. Regadenoson 0.05mg Receives: Drug: Regadenoson 0.05mg
Arm 2 regadenoson 0.1mg	Experimental	Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose. Receives: Drug: Regadensoson 0.1mg
Arm 3 regadenoson 0.2mg	Experimental	Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose. Receives: Drug: Regadensoson 0.2mg
Arm 4 regadenoson 0.4mg	Experimental	Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose. Receives: Drug: Regadensoson 0.4mg
Arm 5 regadenoson 0.7mg	Experimental	Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose. Receives: Drug: Regadensoson 0.7mg
Arm 6 regadenoson 1.0mg	Experimental	Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose. Receives: Drug: Regadensoson 1.0mg
Arm 7 regadenoson 1.4mg	Experimental	Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose. Receives: Drug: Regadensoson 1.4mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose of regadenoson
Dose of regadenoson which results in an increase of gadolinium Ktrans by over 10 times.
Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 20192 Oct 2023

First posted3 Jun 2019
Study start6 Dec 2019
Primary completion30 Apr 2022
Study completion2 Oct 2023

Why it stopped: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for High Grade GliomaStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Seven dose levels of Regadenoson will be studied in part 1, minimum 3 patients per dose level. Part 2 will include 5 patients at each level that achieved thresh hold in part 1
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03971734
Sponsor's protocol ID: ABTC 1804
Other IDs: UM1CA137443
Status last verified: Oct 2023
First submitted: 31 May 2019
Last updated: 6 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Grossman SA, Romo CG, Ye X, Kral B, Strowd RE, Lesser G, Raymond C, Iacoboni M, Desideri S, Fisher J, Danda N, Ellingson BM. Assessing the dose of regadenoson required to transiently alter blood-brain barrier integrity in patients with infiltrating gliomas. Neurooncol Adv. 2025 Feb 15;7(1):vdaf041. doi: 10.1093/noajnl/vdaf041. eCollection 2025 Jan-Dec.
PubMed 40225909

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
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RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 1
Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas
Currently Only Enrolling Glioblastoma Patients at First Recurrence

All High Grade Glioma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determining the Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas
ClinicalTrials.gov ID: NCT03971734
Acronym / sponsor ID: ABTC 1804
Conditions: High Grade Glioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Glioblastoma
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]
Enrolment: 7 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 6 Dec 2019 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 2 Oct 2023 (actual)
First posted: 3 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

Part I Treatment Plan

Part II Treatment Plan

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7
Model description: Seven dose levels of Regadenoson will be studied in part 1, minimum 3 patients per dose level. Part 2 will include 5 patients at each level that achieved thresh hold in part 1

Arm	Type	Receives
Arm 1 regadenoson 0.05mg	Experimental	Drug: Regadenoson 0.05mgApproximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose. Regadenoson 0.05mg
Arm 2 regadenoson 0.1mg	Experimental	Drug: Regadensoson 0.1mgApproximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Arm 3 regadenoson 0.2mg	Experimental	Drug: Regadensoson 0.2mgApproximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Arm 4 regadenoson 0.4mg	Experimental	Drug: Regadensoson 0.4mgApproximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Arm 5 regadenoson 0.7mg	Experimental	Drug: Regadensoson 0.7mgApproximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Arm 6 regadenoson 1.0mg	Experimental	Drug: Regadensoson 1.0mgApproximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Arm 7 regadenoson 1.4mg	Experimental	Drug: Regadensoson 1.4mgApproximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist. The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters. The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (18 listed)

Patients must have histologically confirmed high grade glioma (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), gliosarcoma, and anaplastic oligodendroglioma). Patients with previous low-grade glioma who progressed after RT/chemotherapy and are biopsied and found to have GBM/GS are eligible.
Patients must have measurable contrast-enhancing disease by MRI imaging within 7-14 days of starting treatment (defined by at least 1 cm x 1 cm). Patient must be able to tolerate MRIs with contrast.
Patients must have stable MRI (no progression of disease) for the past 2 months or more.
Patients may have an unlimited number of prior relapses.
The following intervals from previous treatments are required to be eligible:

Key exclusion criteria (18 listed)

Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Patients who are receiving any other investigational agents.
History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to regadenoson.
Patients with any history, current symptoms, or signs of cardiovascular disease including:
Patients who have uncontrolled hypo- or hypertension defined as a systolic blood pressure <90 mmHg or >180 mmHg, respectively.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Regadenoson 0.05mgRegadensoson 0.05mg administered prior to MRI	Drug	Arm 1 regadenoson 0.05mg
Regadensoson 0.1mgRegadensoson 0.1mg administered prior to MRI	Drug	Arm 2 regadenoson 0.1mg
Regadensoson 0.2mgRegadensoson 0.2mg administered prior to MRI	Drug	Arm 3 regadenoson 0.2mg
Regadensoson 0.4mgRegadensoson 0.4mg administered prior to MRI	Drug	Arm 4 regadenoson 0.4mg
Regadensoson 0.7mgRegadensoson 0.7mg administered prior to MRI	Drug	Arm 5 regadenoson 0.7mg
Regadensoson 1.0mgRegadensoson 1.0mg administered prior to MRI	Drug	Arm 6 regadenoson 1.0mg
Regadensoson 1.4mgRegadensoson 1.4mg administered prior to MRI	Drug	Arm 7 regadenoson 1.4mg

Primary outcome

Dose of regadenoson
Time frame: 15 minutes
Dose of regadenoson which results in an increase of gadolinium Ktrans by over 10 times.

Results and safety

The study was stopped early (reason given: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
Derived from this study: PubMed 40225909Grossman SA, Romo CG, Ye X, Kral B, Strowd RE, Lesser G, Raymond C, Iacoboni M, Desideri S, Fisher J, Danda N, Ellingson BM. Assessing the dose of regadenoson required to transiently alter blood-brain barrier integrity in patients with infiltrating gliomas. Neurooncol Adv. 2025 Feb 15;7(1):vdaf041. doi: 10.1093/noajnl/vdaf041. eCollection 2025 Jan-Dec.
Individual participant dataSharing planned: No

Related trials for High Grade Glioma

RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 1
Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas
Currently Only Enrolling Glioblastoma Patients at First Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stuart A Grossman, MD study chair

ABTC

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose of regadenoson (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03971734, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.