TerminatedPhase 2

Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas

Stopped: Insufficient enrollment.

United States1 participantsStarted 2015-06

Plain-language summary

This study will be aimed at investigating the effectiveness of a treatment for brain tumors called Photodynamic Therapy, or PDT. Briefly, a subject will receive a light-sensitive drug, called Photofrin®, the day before a tumor removal surgery. The next day, after the tumor is removed, red light from a laser will be shone into the tumor cavity through a light-diffusing sphere. This light will activate the photosensitizer, and possibly kill any tumor cells that may be left. We plan to measure how long the subject may go without a new tumor regrowth, and overall how long subjects survive. We will compare these results to typical results to see if we are seeing any improvements. Objective: To define the antitumor activity of Photofrin® and laser light activation within the confines of a Phase II study.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age: Greater than or equal to 18 years of age.
✓. Disease: Patients with relapsed or refractory high grade glioma are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse. Tumors must be supratentorial in location.
✓. Disease Status: Patients must have potentially resectable disease.
✓. Therapeutic Options: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
✓. Performance Level: Karnofsky 50% or greater. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
✓. Predictable Life Expectancy: \> 8weeks
✓. Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy. At least three weeks from previous chemotherapy and 4 weeks from prior radiation therapy.
✓. Organ Function:

Exclusion criteria

What they're measuring

Six Month Relapse-free Survival (RFS).

Timeframe: Six months from PDT

Trial details

NCT IDNCT01966809

SponsorHarry T Whelan, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-19

Results submitted2019-07-18

View on ClinicalTrials.gov More Brain Tumor, Recurrent trials