AMG 102 and Avastin for Recurrent Malignant Glioma
The primary purpose of the study is to assess the response rate of AMG 102 and Avastin treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate overall survival and 6-month progression-free survival rates in this population and to assess the safety of this combination in this population.
Patients must have recurrent histologically confirmed diagnosis of World Health Organization (WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at Duke.
In initial Phase I and II clinical trials, four potential Avastin-associated safety issues were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most common side effect for AMG 102 have been nausea and fatigue.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study to Evaluate the Efficacy and Safety of AMG 102 and Avastin in Subjects With Recurrent Malignant Glioma|
- Radiological response rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]Radiological response rates as determined by the Modified McDonald criteria, which incorporates steroid use and clinical status in addition to the tumor response.
- Overall Survival and 6-month progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Incidence and severity of CNS hemorrhage and systemic hemorrhage; Incidence of grade 4 or greater hematologic and grade 3 or greater non-hematologic toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: AMG 102 with Avastin
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
Drug: AMG 102 with Avastin
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102. AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
|Contact: Katherine B Peters, MD, PhDfirstname.lastname@example.org|
|Contact: Alise Brickhouseemail@example.com|
|United States, North Carolina|
|The Preston Robert Tisch Brain Tumor Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Katherine B Peters, MD, PhD 919-684-6173 firstname.lastname@example.org|
|Contact: Alise Brickhouse 919-684-3170 email@example.com|
|Principal Investigator: Katherine B Peters, MD, PhD|
|Principal Investigator: Mary Lou Affronti, RN, MSN, ANP, MHSc|
|Principal Investigator:||Katherine B Peters, MD, PhD||Duke University|
|Principal Investigator:||Mary Lou Affronti, RN, MSN, ANP, MHSc||Duke University|