Study of XIAP Antisense Given With Chemotherapy for Refractory/Relapsed AML
- Conditions
- Leukemia, Myelomonocytic, Acute
- Registration Number
- NCT00363974
- Lead Sponsor
- Aegera Therapeutics
- Brief Summary
The purpose of this study is to determine if the drug, called AEG35156, can be safely given to AML patients and whether it effectively reduces levels of a protein (XIAP) to increase the sensitivity of cancer cells to chemotherapy (ara-C and idarubicin) in patients with refractory or relapsed AML.
- Detailed Description
This is a phase I/II, single-arm, open-label, study to establish the recommended dose and activity of AEG35156 administered as a daily x3 two-hour infusion prior to reinduction chemotherapy with idarubicin and ara-C followed by weekly two-hour AEG35156 infusions. Subjects eligible for study entry must have confirmed diagnosis of AML in first relapse after an initial CR that lasted less than 6 months or primary refractory AML. Fixed dose of idarubicin and ara-C will be given, plus one of eight doses of AEG35156: 12, 24, 48, 75, 110, 165, 250 and 350mg/m2. A maximum of 54 patients will be treated in cohorts of size 3, starting at 12mg/m2, and not skipping any untried dose level when escalating. Following dose escalation, approximately 20 patients will be treated at the best acceptable dose as determined by the method of Thall and Cook (2004).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Dose at which AEG35156 when combined with fixed doses of ara-C and idarubicin, produces acceptable CR and toxicity rates as defined and observed at 30 days post-last dose 1 year
- Secondary Outcome Measures
Name Time Method Effects of AEG35156 on XIAP mRNA and protein expression and plasma pharmacokinetic profile of AEG35156. 1 year
Trial Locations
- Locations (7)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Norris Cancer Center - University of Southern California
🇺🇸Los Angeles, California, United States
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States