Clinical trial
clinical trial
Bortezomib and combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia
Intervention
Drug intervention
Intervention Type
drug intervention
has_intervention
Etoposide/cytarabine
drug intervention
Etoposide/cytarabine
Intervention
intervention
planned process
planned process
process
occurrent
entity
Drug intervention
drug intervention
Bortezomib
drug intervention
Bortezomib
Intervention
intervention
planned process
planned process
process
occurrent
entity
Drug intervention
drug intervention
Idarubicin/cytarabine
drug intervention
Idarubicin/cytarabine
Intervention
intervention
planned process
planned process
process
occurrent
entity
Contact
has contact
has_contact
Berenberg, Jeffrey
PI
has PI
has_PI
Wilkinson, Robert, M.D.
Topic
has topic
has_topic
acute myeloid leukemia
Funded by
funded by
funded_by
Children's Oncology Group
Phase
Phase 2 clinical trial
has phase
has_phase
Phase 2
Performed by
human study performed by
human_study_performed_by
Clinical Protocol & Data Management Shared Resource
http://www.clinicaltrial.gov/ct2/show/NCT00666588?term=Phase+II+Pilot+Study+of+Bortezomib+and+Reinduction+Chemotherapy+in+Younger+Patients+With+Recurrent%2C+Refractory%2C+or+Secondary+Acute+Myeloid+Leukemia&rank=1
ClinicalTrials.gov url
ClinicalTrials.gov url
CTurl
http://www.cancer.gov/clinicaltrials/search/view?cdrid=660550&version=healthprofessional
Website(s)
has URL
has_url
antineoplastic combination chemotherapy
Additional Topic(s)
has_subject_area
The primary objectives of this study are to determine the toxicities and tolerability of bortezomib in combination with standard-relapse acute myeloid leukemia (AML) therapy (idarubicin/cytarabine or etoposide/high-dose cytarabine) in pediatric and young adult patients with relapsed or primary-refractory or secondary AML, and to estimate the complete response rate to the Arm A and Arm B regimens.
This is a multicenter, dose-escalation study of bortezomib. Patients are stratified according to anthracycline-equivalent cumulative exposure (≤ 400 mg/m² vs > 400 mg/m²). Patients are assigned to 1 of 2 groups.
Group 1 (efficacy phase, patients with ≤ 400 mg/m² anthracycline-equivalent cumulative exposure): Patients receive idarubicin IV over 15 minutes on days 1-3, low-dose cytarabine IV continuously over days 1-7, and bortezomib IV on days 1, 4, and 8.
Group 2 (dose-finding phase and efficacy phase, patients with > 400 mg/m² anthracycline-equivalent cumulative exposure): Patients receive etoposide IV over 1 hour on days 1-5, high-dose cytarabine IV over 1 hour twice daily on days 1-5, and bortezomib IV on days 1, 4, and 8.
All patients receive intrathecal cytarabine prior to courses 1 and 2.
In both arms, treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for at least 5 years.
Resource Description
resource_description
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 Leukemi
Additional Name
eagle-i_synonym
90 males and females 1 to 21 years of age.
Study Population
study population
has_study_population
2011-06-22T20:25:42.899-05:00
awendicke (Annemarie Wendicke)
2011-09-23T10:52:44.509-05:00
workflow state
Published
mwilson (Melanie Wilson)
nvasilevsky
Interventional study
Research project
research project
Human Study
human study
human study
planned process
planned process
Quantitative human study
process
occurrent
entity