UNITE Study: Understanding New Interventions With GBM ThErapy
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: Steroid eye drops; Vasoconstrictor eye drops; Cold compress; Ophthalmic steroid ointment; Depatuxizumab mafodotin; Temozolomide; Radiation
Intervention description: Solution, eye drop; Solution, eye drop; Cold compress; Ointment; During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.; Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care.; Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.
Intervention MeSH terms: Temozolomide; Vasoconstrictor Agents; Ophthalmic Solutions; ABT-414
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glioblastoma Multiforme (GBM); Cancer; Chemoradiation therapy; Epidermal growth factor receptor-amplified glioblastoma; Radiation; Temozolomide

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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)