UNITE Study: Understanding New Interventions With GBM ThErapy

Stopped early · Phase 3

Conditions studied: Glioblastoma Multiforme

In brief

The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).

Key facts

Study ID

NCT03419403

Run by

AbbVie

People needed

40

Starts

2018-07-30

Expected to finish

2020-03-03

Last updated by the study team

2021-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM 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 ≤ 21 days prior to randomization
• Participant has a life expectancy of ≥ 3 months

You may not qualify if…

• Participant has received prior chemotherapy or radiotherapy for cancer of the head and neck region
• Participant 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) within 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 hepatitis B virus or hepatitis C virus infection
• Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV)

Where it is running

• Usc /Id# 164235 — Los Angeles, California, United States
• Moffitt Cancer Center /ID# 164234 — Tampa, Florida, United States
• Rush University Medical Center /ID# 171003 — Chicago, Illinois, United States
• Northshore University Health System-Evanston /ID# 164221 — Evanston, Illinois, United States
• CDH-Delnor Health System /ID# 169909 — Warrenville, Illinois, United States
• Columbia University Medical Center /ID# 164220 — New York, New York, United States
• Levine Cancer Ins, Carolina Me /ID# 171271 — Charlotte, North Carolina, United States
• UT Health Science Ctr-Houston /ID# 164223 — Houston, Texas, United States
• Baylor Scott & White Medical Center- Temple /ID# 170792 — Temple, Texas, United States
• Royal North Shore Hospital /ID# 169673 — Saint Leonards, New South Wales, Australia
• Calvary Mater Newcastle /ID# 169672 — Waratah, New South Wales, Australia
• Royal Brisbane and Women's Hospital /ID# 169674 — Herston, Queensland, Australia
• Austin Hospital /ID# 169671 — Heidelberg, Victoria, Australia
• Universitaetsklinik Heidelberg /ID# 169970 — Heidelberg, Baden-Wurttemberg, Germany
• Universitaetsklinikum Leipzig /ID# 169969 — Leipzig, Saxony, Germany
• Klinikum Univ. Regensburg /ID# 169963 — Regensburg, Germany
• Universitatsklinikum Tubingen /ID# 169965 — Tübingen, Germany
• Vrije Universiteit Medisch Centrum /ID# 170152 — Amsterdam, Netherlands
• Universitair Medisch Centrum Utrecht /ID# 170149 — Utrecht, Netherlands
• Guy's and St Thomas' NHS Found /ID# 207752 — London, London, City of, United Kingdom
• Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657 — Birmingham, United Kingdom
• Castle Hill Hospital /ID# 200662 — Cottingham, United Kingdom

Full record on ClinicalTrials.gov

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