A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma

Recruiting in Palo Alto (17 mi)

Overseen byJan Drappatz, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Hemerion Therapeutics

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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 75 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.

Research Team

Jan Drappatz, MD

Principal Investigator

UPMC Presbyterian Shadyside Hospital, Pittsburgh, PA

Eligibility Criteria

Inclusion Criteria

You must be between 18 and 69 years old to participate in the study.

You have signed a form agreeing to follow the rules and limitations explained in the informed consent.

You have recently been diagnosed with a specific type of aggressive brain tumor called glioblastoma multiforme (GBM) based on clinical symptoms and MRI findings.

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