Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients
It has been shown that bevacizumab has significant anti-tumor activity in patients with recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics. Patients will be treated with a combination of bevacizumab and vorinostat.
Recurrent Glioblastoma Multiforme
Adult Brain Tumor
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bevacizumab and Vorinostat for Recurrent WHO Grade IV Malignant Glioma Patients|
- 6-month progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Radiographic Response [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]MRI evaluations for assessment of radiographic response and response will be classified according to the Response Assessment in Neuro-Oncology criteria. Brain MRI will be performed prior to the initiation of every other cycle. Comparisons of objective assessments, excluding progressive disease, are based upon major changes in tumor size on the Gd-MRI scan compared to the baseline scan. Determination of progressive disease is based upon comparison to the previous scan with the smallest measurements.
- Safety & Tolerability [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]Grade 3 or greater, treatment related, non-hematologic toxicities.
- Median progression-free survival [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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: SAHADrug: Bevacizumab
Other Name: Avastin
There is no effective therapy for patients with recurrent glioblastoma multiforme (GBM) hence such patients remain a major unmet need in oncology. The investigators have recently demonstrated that bevacizumab (BV), a humanized monoclonal antibody against vascular endothelial growth factor, has significant anti-tumor activity among recurrent glioblastoma multiforme patients. Vorinostat has modest anti-tumor activity against malignant glioma and can potentiate the action of both chemotherapy and anti-angiogenics. The current study is designed to evaluate the anti-tumor activity of vorinostat when combined with BV among recurrent glioblastoma multiforme patients.
|Contact: Katherine Peters, MD, PhDemail@example.com|
|Contact: Shelley Dutton, BSfirstname.lastname@example.org|
|United States, North Carolina|
|Duke Cancer Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Shelley Dutton, BS 919-668-0673 email@example.com|
|Contact: Katherine Peters, MD, PhD 919-684-3914 firstname.lastname@example.org|
|Principal Investigator: Katherine Peters, MD, PhD|
|Sub-Investigator: Annick Desjardins, MD, FRCPC|
|Sub-Investigator: Henry S Friedman, MD|
|Sub-Investigator: Tulika Ranjan, MD|
|Sub-Investigator: Gordana Vlahovic, MD, MHS|
|Sub-Investigator: Lloyd Alderson, MD, D.Sc.|
|Principal Investigator:||Katherine Peters, MD, PhD||Duke University|