drugset / Trial / NCT00440726

Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

NCT00440726

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

Drugs

EvaluationDrugModalityDoseRoute
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