What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, such as temozolomide and bevacizumab, often combined with radiation therapy, have several known side effects. Temozolomide can cause nausea, vomiting, fatigue, and myelosuppression, leading to increased infection risk. Bevacizumab may result in hypertension, proteinuria, and an increased risk of thromboembolic events. Radiation therapy can cause fatigue, hair loss, and skin changes at the treatment site. These side effects can vary in severity and impact patients' quality of life.

What prior FDA approvals exist?

FDA-approved treatments for glioblastoma include temozolomide, which is often used in combination with radiation therapy, and bevacizumab, an anti-angiogenic agent. Temozolomide is an oral alkylating agent that has shown efficacy in extending survival when used alongside radiotherapy. Bevacizumab targets vascular endothelial growth factor (VEGF) to inhibit tumor blood vessel growth. These treatments are standard for glioblastoma and may be relevant to the ChemoID trial, which aims to tailor chemotherapy based on the chemosensitivity of cancer stem cells.

What other types of research exist?

Promising novel alternatives to ChemoID for Glioblastoma patients in 2024 include: 1) IDH-targeted therapies such as ivosidenib and vorasidenib, which are in clinical trials for IDH-mutant gliomas. 2) Immune checkpoint inhibitors like nivolumab, which have shown potential in various cancers including glioblastoma. 3) Advanced molecular profiling techniques that provide comprehensive tumor genetic and epigenetic landscapes to guide personalized treatment strategies.

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Anti-cancer Drug

ChemoID-Guided Therapy for Glioblastoma (CSCRGBM Trial)

Phase 3

Waitlist Available

Led By Tulika Ranjan, MD

Research Sponsored by Cordgenics, LLC

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 4, 6, 9, and 12 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests if using the ChemoID test to choose chemotherapy drugs can improve outcomes for patients with recurrent glioblastoma (GBM) compared to standard treatments chosen by doctors. The ChemoID test has been evaluated for its effectiveness in selecting personalized chemotherapy for GBM patients.

Who is the study for?

This trial is for adults with confirmed recurrent glioblastoma who can undergo surgery and have certain blood counts within normal ranges. They must not be pregnant, nursing, or have severe kidney issues, and should agree to use contraception if applicable. Those with other recent cancers or using the OPTUNE device are excluded.

What is being tested?

The study tests whether a cancer stem cell test called ChemoID can predict how well patients respond to chemotherapy in recurrent glioblastoma. Participants will receive standard chemotherapy guided by the results of this test.

What are the potential side effects?

Potential side effects include those commonly associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, and possible organ damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Median Overall Survival (OS)

Secondary study objectives

Median Progression Free Survival (PFS)

Objective Tumor Response

Overall Survival at 6, 9, and 12 Months (OS6mo, OS9mo, OS12mo)

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ChemoID-guided treatmentExperimental Treatment2 Interventions

Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. ChemoID-guided treatment will be chosen from the following standard-of-care chemotherapy drugs or combinations: * Carboplatin; * Irinotecan; * Etoposide; * BCNU; * CCNU; * Temozolomide; * Procarbazine; * Vincristine; * Imatinib; * Procarbazine, CCNU, Vincristine; * Carboplatin, Irinotecan; * Carboplatin, Etoposide; * Temozolomide, Etoposide; * Temozolomide, Imatinib. The treating physician will receive the ChemoID assay results from the ChemoID lab.

Group II: Physician Choice treatmentActive Control2 Interventions

Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the Physician from the provided list). Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations: * Carboplatin; * Irinotecan; * Etoposide; * BCNU; * CCNU; * Temozolomide; * Procarbazine; * Vincristine; * Imatinib; * Procarbazine, CCNU, Vincristine; * Carboplatin, Irinotecan; * Carboplatin, Etoposide; * Temozolomide, Etoposide; * Temozolomide, Imatinib. The treating physician will NOT receive the ChemoID assay results from the ChemoID lab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ChemoID assay

2018

Completed Phase 3

~80

Chemotherapy

2003

Completed Phase 4

~3050

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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

Common treatments for Glioblastoma include temozolomide, radiation therapy, and targeted therapies. Temozolomide is an oral alkylating agent that damages the DNA of cancer cells, leading to cell death. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. Targeted therapies, such as bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis. Understanding these mechanisms is crucial for Glioblastoma patients because it helps in selecting the most effective treatment based on the tumor's characteristics, potentially improving outcomes and minimizing side effects.