A Phase II Study of Bortezomib (Velcade, PS-341, IND #58443) in Combination With Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults With Refractory/Recurrent Hodgkin Disease
I. Determine the efficacy and safety of bortezomib (as a chemosensitizing agent) in
pediatric patients and young adults with primary refractory Hodgkin's lymphoma (HL) or HL in
II. Determine response rate in patients treated with bortezomib, ifosfamide, and vinorelbine
ditartrate (vinorelbine tartrate) (IVB) and compare it to the historical response rate in
patients treated with ifosfamide and vinorelbine ditartrate alone.
I. Determine the overall response rate (complete and partial response) and induction success
rate after 2 or 4 courses of therapy and the reinduction rate (complete response) after 4
courses of therapy.
II. Determine the proportion of patients able to mobilize sufficient hematopoietic stem
cells (CD34+) after 2 courses of IVB.
OUTLINE: This is a multicenter, open-label, pilot study.
Patients receive ifosfamide intravenously (IV) continuously over days 1-4, vinorelbine
tartrate IV over 6-10 minutes on days 1 and 5, bortezomib IV on days 1, 4, and 8, and
filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts
recover or peripheral blood stem cells (PBSC) are harvested. Treatment repeats every 21 days
for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo autologous PBSC harvesting according to institutional guidelines after the
second course of therapy.
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of complete response between IVB and historical controls of IV after 2 courses
Compared using a two sample test for proportions. 95% confidence interval will be calculated.
At 42 days
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|