UNITE Study: Understanding New Interventions With GBM ThErapy

Status Terminated

Clinical Trial 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).

Clinical Trial Description

This Phase 3b open-label, randomized, exploratory study included 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids; standard steroids with vasoconstrictors and cold compress; and enhanced steroids with vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03419403
Study type	Interventional
Source	AbbVie
Contact
Status	Terminated
Phase	Phase 3
Start date	July 30, 2018
Completion date	March 3, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05023551` - Study of DSP-0390 in Patients With Recurrent High-Grade Glioma	Early Phase 1
Recruiting	`NCT06059690` - Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells	Phase 1/Phase 2
Recruiting	`NCT04116411` - A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients	Phase 2
Terminated	`NCT01902771` - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors	Phase 1
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Completed	`NCT02386826` - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme	Phase 1
Completed	`NCT00038493` - Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme	Phase 2
Withdrawn	`NCT03980249` - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells	Early Phase 1
Recruiting	`NCT01923922` - CT Perfusion in the Prognostication of Cerebral High Grade Glioma	N/A
Completed	`NCT01956734` - Virus DNX2401 and Temozolomide in Recurrent Glioblastoma	Phase 1
Completed	`NCT01301430` - Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.	Phase 1/Phase 2
Suspended	`NCT01386710` - Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma	Phase 1/Phase 2
Completed	`NCT01402063` - PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation	Phase 2
Active, not recruiting	`NCT00995007` - A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas	Phase 2
Terminated	`NCT00990496` - A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)	Phase 1
Terminated	`NCT01044966` - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma	Phase 1/Phase 2
Completed	`NCT00402116` - Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients	Phase 1/Phase 2
Completed	`NCT00112502` - Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme	Phase 2
Completed	`NCT00504660` - 6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients	Phase 2
Recruiting	`NCT05366179` - Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc	Phase 1