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IA Carboplatin + IA Caelyx for Glioblastoma

Phase 2

Recruiting

Led By David Fortin, MD

Research Sponsored by Université de Sherbrooke

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 when death is reported; through study completion, an average of 2 years

Awards & highlights

Study Summary

"This trial is testing a new treatment approach for glioblastoma, a type of brain cancer. The current standard treatment involves surgery, radiation, and chemotherapy, but relapse is common. This trial

Who is the study for?

This trial is for individuals with glioblastoma that has recurred or is relapsing. Participants must have already undergone standard treatment including surgery, radiotherapy, and temozolomide. They should be eligible for additional surgery if needed and able to receive intraarterial chemotherapy.Check my eligibility

What is being tested?

The study tests two combinations of intraarterial chemotherapy: Carboplatin with Caelyx versus Carboplatin with Etoposide Phosphate in patients whose glioblastoma has progressed after initial treatment. The goal is to improve progression-free survival (PFS) and overall survival (OS).See study design

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to lowered blood counts, potential kidney or liver damage, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ when death is reported; through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~when death is reported; through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and when death is reported; through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-free Survival

Tumor Response on MRI using the RANO Criteria

Secondary outcome measures

Incidence of treatment related Neurocognitive decline

Median overall survival

Per treatment quality of life assessment

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: IA Carboplatin + IA Etoposide PhosphateExperimental Treatment1 Intervention

Participants will be treated with IA carboplatin + IA etoposide phosphate on each cycle (4-6 weeks), for up to 12 cycles.

Group II: IA Carboplatin + IA CaelyxExperimental Treatment1 Intervention

Participants will be treated with IA carboplatin + IA liposomal doxorubicin on each cycle (4-6 weeks), for up to 12 cycles.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor

295 Previous Clinical Trials

69,529 Total Patients Enrolled

1 Trials studying Glioblastoma

35 Patients Enrolled for Glioblastoma

David Fortin, MDPrincipal InvestigatorEstrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

1 Previous Clinical Trials

35 Total Patients Enrolled

1 Trials studying Glioblastoma

35 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial currently accepting new participants?

"As per clinicaltrials.gov, this research study is actively pursuing participants. It was first listed on 4/1/2024 and last modified on 4/4/2024."

Answered by AI

What is the current size of the study population participating in this clinical trial?

"The information on clinicaltrials.gov affirms that this investigation is currently enrolling participants. The trial was first shared on April 1st, 2024, and last revised on April 4th, 2024. A total of 120 patients are sought from a single designated site."

Answered by AI

Could you elaborate on the safety profile of IA Carboplatin + IA Caelyx in patients?

"Based on our team's evaluation, the safety rating for IA Carboplatin + IA Caelyx in this Phase 2 trial is rated at 2. This indicates that while some safety data exists, there is currently no evidence supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma

David Fortin 2024. "Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06356883.