drugset / Trial / NCT00440726
Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.
Timeline
- Start
- 2006-08-04
- Primary completion
- 2011-02-26
- Completion
- 2011-02-26
Publications
- Results Messinger Y, Gaynon P, Raetz E, Hutchinson R, Dubois S, Glade-Bender J, Sposto R, van der Giessen J, Eckroth E, Bostrom BC. Phase I study of bortezomib combined with chemotherapy in children with relapsed childhood acute lymphoblastic leukemia (ALL): a report from the therapeutic advances in childhood leukemia (TACL) consortium. Pediatr Blood Cancer. 2010 Aug;55(2):254-9. doi: 10.1002/pbc.22456.
- Results Messinger YH, Gaynon PS, Sposto R, van der Giessen J, Eckroth E, Malvar J, Bostrom BC; Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) Consortium. Bortezomib with chemotherapy is highly active in advanced B-precursor acute lymphoblastic leukemia: Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) Study. Blood. 2012 Jul 12;120(2):285-90. doi: 10.1182/blood-2012-04-418640. Epub 2012 May 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 16 mg | Intrathecal |
| Background | Cytarabine | Small molecule | 20 mg | Intrathecal |
| Background | Cytarabine | Small molecule | 24 mg | Intrathecal |
| Background | Cytarabine | Small molecule | 30 mg | Intrathecal |
| Background | Cytarabine | Small molecule | 50 mg | Intrathecal |
| Background | Cytarabine | Small molecule | 70 mg | Intrathecal |
| Background | Dexamethasone | Small molecule | 10 mg/m2 | Oral |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Hydrocortisone | Other / unclassified | 8 mg | Intrathecal |
| Background | Hydrocortisone | Other / unclassified | 10 mg | Intrathecal |
| Background | Hydrocortisone | Other / unclassified | 12 mg | Intrathecal |
| Background | Hydrocortisone | Other / unclassified | 15 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 8 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 10 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 12 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 15 mg | Intrathecal |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 unknown | Intramuscular |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |