Overview

Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)

Status:
Terminated
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
Both of bortezomib and vorinostat have identified Phase II doses for pediatric and adult patients of which no grade 4 dose limiting toxicities have been observed in prior studies. The pre-clinical synergy of these 2 agents when used in combination along with the lack of over-riding toxicities and different mechanisms of action provide strong rationale for a clinical trial investigating bortezomib and vorinostat in combination. This trial will use the identified Phase II dose which is at or below the maximum tolerated dose for both agents which have very acceptable toxicity profiles and such should prove feasible and tolerable in this relapsed/refractory ALL population.
Phase:
Phase 2
Details
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborator:
Millennium Pharmaceuticals, Inc.
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Imatinib Mesylate
Methotrexate
Vorinostat