Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT04590664
Trial Phases:	Phase I Phase II	Protocol IDs:	WINSHIP5070-20 (primary) NCI-2020-05187
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04590664

Summary

This phase I/II trial studies the side effects and best dose of Verteporfin and to see how well it works in treating patients with high grade EGFR-mutated glioblastoma that has come back (recurrent). Verteporfin may increase body's sensitivity to light, which may help to kill cancer cells.

Objectives

PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of successively higher doses of liposomal verteporfin and determine the maximum tolerated dose (MTD) in study participants with recurrent EGFR positive (+) glioblastoma (GBM). (Phase I)
II. To evaluate the anti-tumor activity of liposomal verteporfin by assessing progression-free survival (PFS) and overall survival (OS). (Phase II)
III. To describe the response rate of EGFR+ GBM in study participants treated with liposomal verteporfin. (Phase II)

SECONDARY OBJECTIVES:
I. To evaluate the anti-tumor activity of liposomal verteporfin by assessing progression-free survival (PFS) and overall survival (OS). (Phase I)
II. To describe the response rate of EGFR+ GBM in study participants treated with liposomal verteporfin. (Phase I)
III. To describe pharmacokinetics of liposomal verteporfin administered on a weekly schedule. (Phase I)
IV. To evaluate the safety and tolerability of successively higher doses of liposomal verteporfin in study participants with recurrent EGFR+ GBM. (Phase II)

OUTLINE: This is a dose-escalation study.

Patients receive verteporfin intravenously (IV) over 63 minutes weekly for 6 weeks in cycle 1, then weekly for 5 weeks in subsequent cycles. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 12 weeks.

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