Study on Verteporfin for Treating Recurrent High Grade EGFR-Mutated Glioblastoma

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04590664

Provider View

This clinical trial is testing the safety and effectiveness of a drug called Visudyne (verteporfin) for treating patients with high grade glioblastoma, a type of brain cancer, that has returned and has a specific mutation (EGFR).

Patient Parameters

Program Overview

This study is exploring the use of Visudyne (verteporfin), a drug usually used for eye diseases, to treat recurrent high grade glioblastoma with an EGFR mutation. The trial aims to find the best dose and see how well the drug works in shrinking tumors. Visudyne is given like chemotherapy to target and kill cancer cells that may be sensitive to it.

Description

The study is divided into two phases. In Phase I, the focus is on finding the safest dose of Visudyne by gradually increasing the amount given to patients and monitoring for side effects. In Phase II, researchers will evaluate how well the drug works in stopping tumor growth and improving survival rates.

Participants will receive Visudyne through an IV once a week for six weeks in the first cycle, and then weekly for five weeks in the following cycles. Each cycle lasts six weeks, and treatment continues as long as the cancer does not worsen and side effects are manageable.

After finishing the treatment, patients will have follow-up visits 30 days later and then every 12 weeks to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent or progressive grade 4 glioma (glioblastoma) and have received standard initial treatment, including radiation and temozolomide.
  • Tumors must have a specific EGFR mutation, determined by standard tests.
  • Show evidence of tumor progression on an MRI scan.
  • May be receiving bevacizumab and show progression while on it.
  • Must be willing to have a central venous access device placed for IV treatments.
  • Have an ECOG performance status of 0-3, indicating varying levels of activity and health.
  • Have manageable medical conditions, except for certain neurological issues related to the brain tumor.
  • Expected to complete at least one cycle of treatment before significant health decline.
  • Must have completed prior radiation to the brain at least 90 days before starting the study.
  • Must have had any major surgery at least 21 days before starting the study.
  • Can continue using a Novo-tumor treating fields therapy device if desired.
  • Must sign a written informed consent.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 8 weeks after.
  • Men must agree to use contraception during the study and for 8 weeks after.

Exclusion Criteria

  • Cannot participate if tumor progression is based only on new symptoms without MRI changes.
  • Cannot participate if swelling is due to radiation effects rather than tumor progression.
  • Pregnant or breastfeeding women cannot participate.
  • Cannot have severe medical conditions or lab abnormalities, except for certain neurological issues related to the brain tumor.
  • Must be able to comply with study safety monitoring.
  • Cannot have conditions that would make study procedures unsafe or affect the ability to consent.
  • Cannot have hereditary porphyria.

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