Study:
A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND #58,443) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
Rationale:
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth
of cancer cells, either by killing the cells or by stopping them from dividing. Giving
bortezomib together with combination chemotherapy may kill more cancer cells.
Purpose:
This phase II trial is studying the side effects of giving bortezomib together with
combination chemotherapy and to see how well it works in treating young patients with
relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma.
Study Status: Recruiting
Recruiting:
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
| Condition |
Intervention |
Phase |
Leukemia
Lymphoma |
Biological: filgrastim
Drug: asparaginase
Drug: asparaginase Erwinia chrysanthemi
Drug: bortezomib
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide phosphate
Drug: leucovorin calcium
Drug: methotrexate
Drug: pegaspargase
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate |
Phase 2 |
Verified by
Children`s Oncology Group
November, 2012
Sponsored by: Children`s Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00873093
Study Type: Interventional
Study Design: Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Terzah M. Horton, MD, PhD., Study Chair