TRC105 for Recurrent Glioblastoma
- Glioblastoma is an aggressive type of brain cancer that often resists treatment. TRC105 is an experimental drug that blocks the growth of new blood vessels. It is being studied for possible use in treating different kinds of cancer. Researchers want to see if TRC105 can be used to treat glioblastoma that has not responded to standard treatments.
- To test the safety and effectiveness of TRC105 in adults who have glioblastoma that has not responded to standard treatments.
- Individuals at least 18 years of age who have glioblastoma that has not responded to standard treatments.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and other tests will be used to study the tumor before the start of treatment.
- Participants will have 28-day (4-week) cycles of treatment.
- Participants will have TRC105 intravenously once a week. The first infusion will take about 4 hours. The length of time needed for the infusion may be slowly reduced if it is well tolerated.
- At the end of the first cycle (the first 4 weeks), the imaging studies will be repeated before continuing TRC105.
- Participants will take TRC105 for as long as the tumor does not grow and the side effects are not too severe. They will have imaging studies at the end of every cycle to evaluate the tumor.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of TRC105 in Patients With Recurrent Glioblastoma (GBM)|
- Radiographic Response Rate for Patients With Recurrent Glioblastoma Multiforme (GBM) Treated With TRC105. [ Time Frame: 14 months ] [ Designated as safety issue: No ]Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is >/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a >/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,
- Number of Participants With Adverse Events [ Time Frame: 5 months, 28 days ] [ Designated as safety issue: Yes ]Here is the number of participants with adverse events. For details, see the adverse event module.
|Study Start Date:||December 2012|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Experimental: TRC105 for Recurrent Glioblastoma||
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778530
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Joohee Sul, M.D.||National Cancer Institute (NCI)|