What side effects are associated with this type of intervention?

The most common treatments for glioblastoma, such as temozolomide and radiotherapy, have several known side effects. Temozolomide can cause nausea, vomiting, fatigue, and myelosuppression, which includes decreased levels of white blood cells, red blood cells, and platelets, leading to an increased risk of infection, anemia, and bleeding. Radiotherapy can result in fatigue, hair loss at the treatment site, skin changes, and potential neurocognitive effects such as memory loss and difficulty concentrating. Combining these treatments may enhance these side effects, necessitating careful monitoring and supportive care.

What prior FDA approvals exist?

Temozolomide (TMZ) is an FDA-approved oral chemotherapy drug commonly used in combination with radiotherapy for the treatment of glioblastoma. This combination is considered the standard of care for newly diagnosed glioblastoma. The approval of temozolomide was based on its ability to improve survival rates when used alongside radiotherapy. Additionally, Tumor Treating Fields (TTF) therapy, which uses electric fields to disrupt cancer cell division, has also been approved for use in combination with temozolomide for glioblastoma treatment. These therapies aim to enhance the efficacy of traditional treatments like radiotherapy.

What other types of research exist?

Promising novel alternatives to Debio 0123 for glioblastoma patients include: 1) ONC201, an investigational oral compound targeting H3 K27M-mutant gliomas, showing potential in early trials. 2) Boron Neutron Capture Therapy (BNCT), which has been evaluated in phase II studies for glioblastoma. 3) Ivosidenib and Vorasidenib, IDH1/2 inhibitors in clinical trials for IDH-mutant gliomas. 4) Chimeric Antigen Receptor (CAR) T-cell therapy targeting GD2 in H3 K27M-mutant gliomas. These therapies represent cutting-edge approaches that may offer new hope for glioblastoma patients.

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Debio 0123 + Temozolomide for Glioblastoma

Phase 1 & 2

Recruiting

Research Sponsored by Debiopharm International SA

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 until disease progression or end of study (approximately 66 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called Debio 0123 combined with standard treatments for adults with aggressive brain cancer. It aims to find the best dose, ensure safety, and check if it works better than current treatments.

Who is the study for?

Adults with recurrent or newly diagnosed glioblastoma who've had limited prior treatments can join this trial. They must have a performance status indicating they're mostly independent, stable minor symptoms like seizures, and their major organs should be functioning well. Participants need to commit to the study schedule and agree to use effective birth control.

What is being tested?

The trial is testing Debio 0123 in combination with Temozolomide (TMZ), both alone and alongside radiotherapy for glioblastoma patients. Phase 1 determines the safest dose while Phase 2 compares its effectiveness against standard care.

What are the potential side effects?

Potential side effects of Debio 0123 are not specified but may include typical reactions related to chemotherapy such as nausea, fatigue, blood cell count changes, and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until disease progression or end of study (approximately 66 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until disease progression or end of study (approximately 66 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until disease progression or end of study (approximately 66 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

Phase 1 (Dose Escalation): Change From Baseline in Karnofsky Performance Status (KPS) Score

Secondary study objectives

Phase 1 (Dose Escalation): Plasma Concentration of Temozolomide

Phase 1 (Dose Expansion): Change From Baseline in KPS Score

Phase 2: Change From Baseline in KPS Score

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase 2: Debio 0123 RD + TemozolomideExperimental Treatment2 Interventions

Participants will receive intermittent Debio 0123 RD along with TMZ in each 28-day cycle for up to 2 years.

Group II: Phase 1 (Dose Expansion): Debio 0123 + TemozolomideExperimental Treatment2 Interventions

Participants will receive Debio 0123, escalating doses along with temozolomide (TMZ) in each 28-day cycle for up to 2 years. Participants will receive one of the 2 selected doses for further investigation.

Group III: Phase 1 (Dose Escalation): Arm C - Debio 0123 + Temozolomide + RadiotherapyExperimental Treatment3 Interventions

Participants will receive intermittent Debio 0123, escalating doses along with TMZ and concomitant administration of radiotherapy (RT) for up to 6 weeks.

Group IV: Phase 1 (Dose Escalation): Arm B - Debio 0123 + Temozolomide + RadiotherapyExperimental Treatment3 Interventions

Participants will receive intermittent Debio 0123, escalating doses along with TMZ and concomitant administration of radiotherapy (RT) for up to 6 weeks. As per Protocol _V4.0 Arm B has been permanently halted.

Group V: Phase 1 (Dose Escalation): Arm A - Debio 0123 + TemozolomideExperimental Treatment2 Interventions

Participants will receive intermittent Debio 0123, escalating doses along with temozolomide (TMZ) in each 28-day cycle for up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

Temozolomide

2010

Completed Phase 3

~1880

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

Temozolomide is an oral chemotherapy drug that works by methylating DNA, which leads to DNA damage and triggers cell death in rapidly dividing tumor cells. Radiotherapy uses high-energy radiation to damage the DNA of cancer cells, inhibiting their ability to replicate and causing cell death. Debio 0123 is being studied for its potential to enhance the effects of temozolomide and radiotherapy by possibly increasing the sensitivity of glioblastoma cells to these treatments. This combination aims to improve treatment efficacy, offering hope for better outcomes in glioblastoma patients, who typically face a poor prognosis with standard therapies.