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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor: Masonic Cancer Center, University of Minnesota
Study ID: NCT01312818
Phase: PHASE2
Status: Terminated

Conditions

Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: ALL
Age: 2 Years - 30 Years
Healthy Volunteers: Not accepted

Interventions

Bortezomib — DRUG
1.3 mg/m\^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
Vorinostat — DRUG
180 mg/m\^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
Dexamethasone — DRUG
6 mg/m\^2 by mouth (PO) divided twice a day (BID) on days 4-15.
Methotrexate — DRUG
Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
Imatinib mesylate — DRUG
For Ph+ acute lymphoblastic leukemia (ALL) patients only: Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for \>18 years on Days 1-16.

Study Details

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.