← Back to Search

Not Applicable

200 J/cm^2 for Glioblastoma

Phase 1 & 2
Recruiting
Led By Jan Drappatz, MD
Research Sponsored by Hemerion Therapeutics
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 6 months
Awards & highlights

Summary

The primary objective of this clinical trial is to determine the safety and tolerability of two doses of light in intraoperative PDT added to standard of care; temozolomide-based chemotherapy in male and female patients aged 18 to 69 with newly diagnosed glioblastoma. This treatment will be carried out in addition to the maximal surgical resection. Data collected during this trial will be used to design the upcoming pivotal study . The study will utilize an independent Data and Safety Monitoring Board (iDSMB) that will review safety data to allow dose escalation.

Eligible Conditions
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Maximal Tolerated Dose (MDT) of light for Photodynamic Therapy
Secondary study objectives
Number of Adverse Events and Serious Adverse Events (Safety and Tolerability)
Treatment response / Progression-free survival (PFS)
Other study objectives
Immune response after intraoperative PDT
Usability of the Heliance® Solution in the operating room

Trial Design

2Treatment groups
Experimental Treatment
Group I: 400 J/cm^2Experimental Treatment1 Intervention
Patient will undergo intraoperative Photodynamic therapy at 400 J/cm\^2
Group II: 200 J/cm^2Experimental Treatment1 Intervention
Patient will undergo intraoperative Photodynamic therapy at 200 J/cm\^2

Find a Location

Who is running the clinical trial?

Hemerion TherapeuticsLead Sponsor
2 Previous Clinical Trials
41 Total Patients Enrolled
1 Trials studying Glioblastoma
21 Patients Enrolled for Glioblastoma
Jan Drappatz, MDPrincipal InvestigatorUPMC Presbyterian Shadyside Hospital, Pittsburgh, PA
1 Previous Clinical Trials
64 Total Patients Enrolled
1 Trials studying Glioblastoma
64 Patients Enrolled for Glioblastoma
~5 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top