What side effects are associated with this type of intervention?

The most common treatments for Glioblastoma include radiation therapy, chemotherapy (such as temozolomide), and investigational therapies like ONC201 and DNX-2401. Radiation therapy can cause side effects such as fatigue, hair loss, and skin changes. Chemotherapy with temozolomide often leads to nausea, vomiting, fatigue, and myelosuppression. Investigational therapies like ONC201 may involve side effects related to mitochondrial metabolism and stress response pathways, while DNX-2401, an oncolytic adenovirus, may cause inflammation and flu-like symptoms. These treatments aim to manage the tumor but come with a range of potential adverse effects that need to be monitored.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, which is often used in combination with radiation therapy. Bevacizumab, an anti-angiogenic therapy, has also been approved for recurrent Glioblastoma. Investigational therapies, such as the oral compound ONC201, are under active investigation for H3 K27-altered midline gliomas, which include Glioblastoma. These treatments focus on targeting specific genetic mutations and pathways involved in tumor growth and progression.

What other types of research exist?

Promising novel alternatives to traditional tumor biopsy for genetic mutation analysis in glioblastoma patients include liquid biopsy, which analyzes circulating tumor DNA (ctDNA) in blood samples, and advanced imaging techniques like magnetic resonance spectroscopy (MRS) to detect specific metabolites associated with genetic mutations.

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Procedure

Tissue Preservation for Glioblastoma

N/A

Waitlist Available

Led By Alireza Mohammadi, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing if taking multiple samples of a brain tumor during surgery can help researchers understand the changes that occur in the tumor cells.

Who is the study for?

This trial is for individuals with a high-grade brain tumor called glioblastoma, visible on MRI scans. They must have a significant amount of tumor tissue (at least 15 cc), be in good physical condition (Karnofsky score ≥70), and have normal blood, kidney, and coagulation lab values. Pregnant individuals or those with conditions that could affect the study's outcome are excluded.Check my eligibility

What is being tested?

The trial is using the NICO Myriad device and Tissue Preservation System to collect multiple samples from different areas of brain tumors during surgery. The goal is to understand how mutations vary within the tumor which may improve diagnosis and treatment strategies.See study design

What are the potential side effects?

While specific side effects aren't listed for this procedure-focused trial, potential risks may include typical surgical complications such as infection, bleeding, reaction to anesthesia, or changes in brain function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility, as measured by percentage of the sample deemed viable by flow cytometry

Other outcome measures

DNA methylation status in tumor regions

Gene expression in tumor regions

Number of somatic mutations per region

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tissue Preservation System (TPS)Experimental Treatment1 Intervention

Tumor tissue will be obtained, processed, and then transported remotely to undergo multiple tests, including gene panel DNA sequencing, DNA methylation array, and bulk as well as single-cell transcriptome analyses (RNA-seq)

Do I qualify?Apply below to find out

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 Glioblastoma include surgery, radiation therapy, and chemotherapy with temozolomide. Surgery aims to remove as much of the tumor as possible, reducing tumor burden. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. Temozolomide, an oral alkylating agent, works by adding alkyl groups to DNA, leading to DNA damage and cell death, particularly in rapidly dividing tumor cells. Understanding the genetic mutations in Glioblastoma, such as IDH1/2 mutations, can help tailor these treatments more effectively. For instance, tumors with MGMT promoter methylation are more responsive to temozolomide. Genetic mutation analysis from tumor biopsies can thus guide personalized treatment plans, potentially improving outcomes for patients.

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Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

455 Previous Clinical Trials

31,811 Total Patients Enrolled

15 Trials studying Glioblastoma

428 Patients Enrolled for Glioblastoma

Alireza Mohammadi, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

~2 spots leftby Dec 2024

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