A phase 2 study of bortezomib in combination with ifosfamide/vinorelbine in paediatric patients and young adults with refractory/recurrent Hodgkin lymphoma: a Children's Oncology Group study
Terzah M Horton, Richard A Drachtman, Lu Chen, Peter D Cole, Kathleen McCarten, Stephan Voss, Robert P Guillerman, Allen Buxton, Scott C Howard, Shirley M Hogan, Andrea M Sheehan, Dolores López-Terrada, Matthew D Mrazek, Neeraj Agrawal, Meng-Fen Wu, Hao Liu, Pedro A De Alarcon, Tanya M Trippet, Cindy L Schwartz, Terzah M Horton, Richard A Drachtman, Lu Chen, Peter D Cole, Kathleen McCarten, Stephan Voss, Robert P Guillerman, Allen Buxton, Scott C Howard, Shirley M Hogan, Andrea M Sheehan, Dolores López-Terrada, Matthew D Mrazek, Neeraj Agrawal, Meng-Fen Wu, Hao Liu, Pedro A De Alarcon, Tanya M Trippet, Cindy L Schwartz
Abstract
A Children's Oncology Group clinical trial aimed to determine if bortezomib (B) increased the efficacy of ifosfamide and vinorelbine (IV) in paediatric Hodgkin lymphoma (HL). This study enrolled 26 relapsed HL patients (<30 years) treated with two to four cycles of IVB. The primary endpoint was anatomic complete response (CR) after two cycles. Secondary endpoints included overall response (OR: CR + partial response) at study completion compared to historical controls [72%; 95% confidence interval (CI): 59-83%]. Although few patients achieved the primary objective, OR with IVB improved to 83% (95% CI: 61-95%; p = 0.32). Although not statistically different, results suggest IVB may be a promising combination.
Trial registration: ClinicalTrials.gov NCT00381940.
Keywords: NF-κB; childhood haematological malignancies; clinical trials; paediatric oncology.
© 2015 John Wiley & Sons Ltd.
Figures
Source: PubMed