Tivozanib for Recurrent Glioblastoma
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the study drug tivozanib is still being studied. It also means that the FDA has not yet approved tivozanib for your type of cancer.
Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it requires to grow.
In this research study, we are looking to see what effects, good and bad, tivozanib will have on you and your disease.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Tivozanib in Recurrent Glioblastoma|
- Determine proportion of patients alive and progression free after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]To determine the proportion of patients with recurrent glioblastoma (GBM) alive and progression free 6 months (PFR6) after start of tivozanib therapy
- Determine safety of tivozanib [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To determine the safety of tivozanib in this patient population
- Determine progression free and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the progression free and overall survival of patients with recurrent GBM treated with tivozanib
- Determine radiographic response using standard CE cranial MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine radiographic response using standard contrast-enhanced cranial MRI techniques
- Assess the steroid dose/duration before, during and after treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]To assess the steroid dose/duration before, during and after treatment with tivozanib
- Assess the correlation of treatment outcome to specific serial circulating cytokines/receptors [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assess the correlation of treatment outcome to specific serial circulating cytokines/receptors and cell populations to determine whether these markers can be predictive of response to tivozanib (exploratory)
- Assess effect of tivozanib on GBM tumor growth [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assess the effect of tivozanib on GBM tumor growth by using physiologic MRI parameters of perfusion, permeability, oxygenation status, diffusion, kurtosis and functional connectivity and resting-state networks
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
1.5 mg daily for 3 weeks, with 1 week off.
Other Name: AV-951
If you are willing to participate in this study, you will be asked to undergo some screening tests and procedures that confirm you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out taht you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. The screening process may include the following: a medical history, mini-mental status exam, physical exam, performance status, electrocardiogram, blood tests, urine test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks) during which time you will be taking the study drug once daily for 3 weeks and then no study drug for the last week of each cycle. The diary will also include special instructions for taking the study drug.
During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
Standard contrast-enhanced (CE) MRI scans will be done prior to all odd-numbered study cycles. Vascular MRI scans will be done prior to start of treatment, Day 1 of treatment and prior to all even-numbered cycles. These studies will be done in the Charlestown Navy Yard.
We would like to keep track of your medical condition for up to 24 months after your last dose of study treatment. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846871
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Elizabeth Gerstner, MD||Massachusetts General Hospital|