Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients
|ClinicalTrials.gov Identifier: NCT01738646|
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : October 29, 2015
Last Update Posted : March 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Glioblastoma Multiforme Malignant Glioma Adult Brain Tumor||Drug: Vorinostat Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bevacizumab and Vorinostat for Recurrent WHO Grade IV Malignant Glioma Patients|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||February 2016|
Experimental: Vorinostat & Bevacizumab
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
Other Name: SAHA
Other Name: Avastin
- Six-month Progression-free Survival (PFS6) [ Time Frame: 6 months ]The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of non-measurable disease. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.
- Radiographic Response [ Time Frame: 3 Years ]The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every second cycle (every 8 weeks) thereafter.
- Percentage of Participants Who Experience Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities. [ Time Frame: 2.7 Years ]The percentage of participants who experience grade 3 or greater, treatment-related, non-hematologic toxicities will be calculated.
- Median Progression-free Survival (PFS) [ Time Frame: 3 Years ]Progression-free survival is defined as the time in months from the start of protocol treatment until the date of progression or death if death occurred before progression. If the participant is alive and progression-free, PFS will be censored at the date of last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.
- Median Overall Survival (OS) [ Time Frame: 3 Years ]Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738646
|United States, North Carolina|
|Duke Cancer Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Katherine Peters, MD, PhD||Duke University|