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Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®

NCT05363826 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-13

No results posted yet for this study

Summary

This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective.

Photodynamic Therapy (PDT) combines light and a photosensitizer. PDT has been used to treat a variety of cancers with varying degrees of success.

For the past thirty years Photolitec has been working to develop a treatment for glioblastoma or gliosarcoma using light and a photosensitizer. Photolitec's scientists were looking for a photosensitizer that:

1. has no significant systemic toxicity apart from some temporary skin photosensitivity,
2. crosses the blood brain barrier,
3. accumulates to a high level in glioblastoma and minimally in the brain,
4. is activated by the wavelength of light that penetrates most deeply into the brain,
5. minimizes any temporary skin photosensitivity.

Preliminary testing indicates the Photolitec team has achieved these five goals. Photolitec is now able to offer a clinical trial based on the results of this work.

Conditions

  • Glioblastoma Multiforme of Brain
  • Glioma, Sarcomatous

Interventions

COMBINATION_PRODUCT

photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)

Intravenous injection of Photobac® 24 hours before surgical removal of recurrent GBMF. Immediately after resection, the cavity will be treated with 50 joules/ square cm of 787nm light. This treatment will add a maximum of 50 minutes to the surgery

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Photolitec LLC

    lead INDUSTRY

Principal Investigators

  • William R Potter, MA · Photolitec LLC

  • Robert Fenstermaker, MD · Roswell Park Dept of Neurosurgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-11
Primary Completion
2025-05-31
Completion
2026-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05363826 on ClinicalTrials.gov