Phase II Temozolomide + Vorinostat in Patients (>60) w/ Newly Diagnosed or Relapse/Refractory AML
The purpose of the study is to first determine if Temozolomide plus Vorinostat in combination can control relapsed or refractory AML and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.
Acute Myeloid Leukemia With 11q23-abnormality in Relapse
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Temozolomide Plus Vorinostat for Elderly Patients (>60) With Newly Diagnosed Acute Myeloid Leukemia (AML) or Relapse/Refractory AML|
- Rate of morphological complete remission [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]The primary endpoint of the study is to determine the clinical efficacy, as determined by the rate of morphological complete remission, of 2 different treatment regimens of temozolomide and vorinostat in patients with AML and poor prognostic features.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: GROUP 1 (Methylated MGMT)
Patients with methylated MGMT promoter (expected to have no expression of MGMT protein expected) will be stratified into group 1 and will be treated with conventional doses of temozolomide (200mg/m2 for 7 days).
100-200 mg/m2/d oral
Active Comparator: GROUP 2 (Non-Methylated MGMT)
2. Patients where the MGMT promoter is not methylated (expected to have expression MGMT protein expected) will be stratified into group 2. These patients will initially receive daily, low doses (protracted dose schedule) of temozolomide (100mg/m2) for 14 days in an attempt to inactivate MGMT activity. Following the protracted dose schedule, patients will be submitted to a repeat bone marrow biopsy to assess the status of the disease and the effects of low dose temozolomide in acute leukemia blasts, and following three days of vorinostat therapy will receive conventional doses of temozolomide for another 7 days.
100-200 mg/m2/d oral
The primary endpoint of the study is to determine the clinical efficacy as determined by the rate of morphological complete remission, of 2 different treatment regimens of temozolomide and vorinostat in patients with AML and poor prognostic features.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550224
|United States, California|
|Stanford University Cancer Institute||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Marlene Zuraek 650-736-4031 firstname.lastname@example.org|
|Sub-Investigator: Steven Coutre, MD|
|Sub-Investigator: Jason Gotlib, MD|
|Sub-Investigator: Michaela Liedtke, MD|
|Principal Investigator:||Bruno Carneiro de Medeiros, MD||Stanford University|