What is the mechanism of action of this treatment?

The most common treatments for brain tumors include radiation therapy, chemotherapy, antiangiogenic therapy, and investigational therapies. Radiation therapy works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate. Chemotherapy, such as temozolomide, interferes with the DNA replication process, leading to cell death. Antiangiogenic therapy, like bevacizumab, targets the blood vessels that supply the tumor, effectively starving it of nutrients. Investigational therapies, such as ONC201 and CAR T-cell therapy, focus on targeting specific molecular pathways and immune responses. Understanding these mechanisms is crucial for brain tumor patients as it helps in tailoring personalized treatment plans and improving outcomes. Advanced brain imaging techniques like MRI and PET play a significant role in monitoring these treatments and predicting tumor mutations, thereby aiding in the timely adjustment of therapeutic strategies.

What side effects are associated with this type of intervention?

Common treatments for brain tumors, including radiation therapy and chemotherapy with temozolomide, often result in side effects such as fatigue, nausea, vomiting, hair loss, and increased risk of infections due to bone marrow suppression. Radiation therapy can also cause localized side effects like skin irritation and neurocognitive deficits. Investigational therapies like ONC201 and DNX-2401 may have unique side effects, but data is still emerging. ONC201 has shown some promise with manageable side effects, while DNX-2401, an oncolytic virus, may cause inflammation and flu-like symptoms. Patients should discuss potential side effects with their healthcare provider to make informed decisions.

What prior FDA approvals exist?

FDA approvals for the treatment of brain tumors, particularly gliomas and glioblastomas, have included drugs like temozolomide, which is often used in combination with radiotherapy. Bevacizumab, an antiangiogenic agent, has also been approved for recurrent glioblastoma. These treatments are part of ongoing efforts to improve outcomes through advanced imaging techniques such as MRI and PET, which are being studied to monitor and predict tumor mutations more effectively.

What other types of research exist?

Promising novel alternatives to advanced brain imaging for brain tumor patients include: 1) Pharmacologic inhibition of histone demethylation, which targets specific genetic mutations in tumors. 2) Chimeric Antigen Receptor (CAR) T-cell therapy targeting GD2, a marker on certain glioma cells. 3) The investigational oral compound ONC201, which has shown efficacy in H3 K27M-mutant gliomas. 4) Local therapies such as DNX-2401, an oncolytic adenovirus administered directly to the tumor site. These alternatives are under active investigation and may offer new avenues for treatment and monitoring in 2024.

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Advanced Imaging and Biopsy Techniques for Brain Tumor (ReGIT Trial)

N/A

Recruiting

Led By Jason Parker, PhD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is between 18 and 89 years of age

Subject has radiologically-diagnosed or suspected WHO Grade II-IV glioma based on physician review or conformance with published WHO criteria as evaluated by the PI

Must not have

Subject has serious unstable medical or mental illness

Subject has insufficient tissue to acquire at least two biopsy samples during resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial uses advanced imaging techniques to take detailed pictures of brain tumors in patients with gliomas. Researchers aim to see if these images can predict genetic changes in the tumors.

Who is the study for?

This trial is for adults aged 18-89 with a newly diagnosed Grade II-IV glioma brain tumor, who can lay still for imaging tests and are planning surgery to remove the tumor. They must be able to read/write in English and not have any conditions that prevent MRI scans.

What is being tested?

The study examines how brain tumors change over time using advanced imaging techniques like MRI/PET scans combined with biopsies. It aims to see if these tools can predict genetic mutations in the tumors.

What are the potential side effects?

Potential side effects may include discomfort from lying still during long imaging sessions, reactions to contrast agents used in MRIs (like allergic reactions or kidney problems), and risks associated with biopsy procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 89 years old.

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My brain tumor is suspected or confirmed to be Grade II-IV glioma.

Select...

I have not received any treatment for my condition yet.

Select...

There is enough of my tumor to take at least 2 biopsy samples during surgery.

Select...

I can stay still during MRI scans.

Select...

I am scheduled for surgery to remove and biopsy my brain tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious or unstable illnesses.

Select...

There isn't enough tissue for two biopsy samples during my surgery.

Select...

I have kidney issues and can't follow certain medication dosing due to my weight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Classification sensitivity

Secondary study objectives

A list of which scans are necessary for statistically valid routine clinical classification of genomic abnormalities.

Accuracy of the mathematical algorithms to predict progression-free survival (PFS) and overall survival (OS).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Baseline Imaging and BiopsyExperimental Treatment5 Interventions

Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CT scan

2013

Completed Phase 2

~2450

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for brain tumors include radiation therapy, chemotherapy, antiangiogenic therapy, and investigational therapies. Radiation therapy works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate. Chemotherapy, such as temozolomide, interferes with the DNA replication process, leading to cell death. Antiangiogenic therapy, like bevacizumab, targets the blood vessels that supply the tumor, effectively starving it of nutrients. Investigational therapies, such as ONC201 and CAR T-cell therapy, focus on targeting specific molecular pathways and immune responses. Understanding these mechanisms is crucial for brain tumor patients as it helps in tailoring personalized treatment plans and improving outcomes. Advanced brain imaging techniques like MRI and PET play a significant role in monitoring these treatments and predicting tumor mutations, thereby aiding in the timely adjustment of therapeutic strategies.

Emerging patents in the therapeutic areas of glioma and glioblastoma.Advances in the treatment of malignant gliomas.