eye disorders Glioblastoma
Conditions
Interventions
Subjects will receive depatuxizumab mafodotin during the chemoradiation phase
(consisting of radiation and temozolomide [RT/TMZ]) and depatuxizumab mafodotin
during adjuvant therapy with TMZ. Depatu
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Participant has a histologically proven, World Health Organization (WHO) grade IV glioblastoma or WHO grade IV gliosarcoma.;• Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.;• Tumors must be supratentorial in location.;• Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.;• Participant has a Karnofsky performance status (KPS) of 70 or higher.;• Participant has adequate bone marrow, renal, and hepatic function.;• Electrocardiogram without evidence of acute cardiac ischemia = 3 months;•Participant has infection with hepatitis B virus (i.e., hepatitis B surface antigen) or hepatitis C virus (i.e., positive for hepatitis C antibody). Subjects who have a history of hepatitis C who have documented cures after anti-viral therapy may be enrolled. Subjects with confirmed positive test result for human immunodeficiency virus (HIV), with CD4 count = 200 cells/microliter within 30 days prior to registration, as the treatments involved in this protocol may be significantly immunosuppressive.
Exclusion criteria
Exclusion criteria: • Participants with newly diagnosed Glioblastoma: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.;• Participant has hypersensitivity to any component of Temozolomide or dacarbazine.;• Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to 5 years of Study Day 1.;• Participant has clinically significant uncontrolled condition(s) as described in the protocol.;• Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.;• Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.;• Participant has a history of herpetic keratitis.;• Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.;• Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.;• Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).;• Participant has infection with hepatitis B virus (i.e., hepatitis B surface antigen) or hepatitis C virus (i.e., positive for hepatitis C antibody). Subjects who have a history of hepatitis C who have documented cures after anti-viral therapy may be enrolled. Subjects with confirmed positive test result for human immunodeficiency virus (HIV), with CD4 count = 200 cells/microliter within 30 days prior to registration, as the treatments involved in this protocol may be significantly immunosuppressive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as the percentage of subjects with either a >= 3-line decline from baseline (>= + 0.3 on LogMAR scale) in visual acuity (with baseline correction), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale, either of which will indicate inadequate control of OSEs requiring a change in OSE management strategy. Unless otherwise noted, visual acuity will be measured using baseline correction, which will be determined at the screening ophthalmology visit and used to assess visual acuity at all remaining ophthalmology visits, for measuring changes in visual acuity and for determining the visual acuity component of the primary endpoint. Details on determining baseline correction are provided in the operations manual. The primary endpoint will be assessed over 8 weeks after initiation of depatuxizumab mafodotin treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Logarithm of the Minimum Angle of Resolution (LogMAR) scale is used to measure visual acuity. The CEAE scale will be used to measure the severity of OSEs. These will be followed over the course of treatment. | — |
Countries
Netherlands
Outcome results
None listed