Study:
A Phase II Pilot Study of Bortezomib (PS-341, Velcade) Combined With Reinduction Chemotherapy in Children and Young Adults With Recurrent, Refractory or Secondary Acute Myeloid Leukemia
Rationale:
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and
etoposide, work in different ways to stop the growth of cancer cells, either by killing the
cells or by stopping them from dividing. Giving more than one drug (combination
chemotherapy) together with bortezomib may kill more cancer cells.
Purpose:
This phase II trial is studying the side effects and best dose of bortezomib and to see how
well it works when given together with combination chemotherapy in treating younger patients
with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop
the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs
used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways
to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may
kill more cancer cells
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Childhood Acute Basophilic Leukemia
Childhood Acute Eosinophilic Leukemia
Childhood Acute Erythroleukemia (M6)
Childhood Acute Megakaryocytic Leukemia (M7)
Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
Childhood Acute Monoblastic Leukemia (M5a)
Childhood Acute Monocytic Leukemia (M5b)
Childhood Acute Myeloblastic Leukemia With Maturation (M2)
Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
Childhood Acute Myelomonocytic Leukemia (M4)
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia |
Drug: idarubicin
Drug: cytarabine
Drug: bortezomib
Drug: etoposide
Other: laboratory biomarker analysis |
Phase 2 |
Verified by
National Cancer Institute (NCI)
December, 2012
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00666588
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Jeffrey Moscow., Principal Investigator