Trial of Temozolomide, Bevacizumab Plus Bortezomib for Recurrent Glioblastoma Multiforme
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Emory University
- Study ID
- NCT01435395
- Phase
- PHASE1
- Status
- Completed
Conditions
- Glioblastoma Multiforme
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Temozolomide, bevacizumab and bortezomib — DRUGEscalating temozolomide with standard dose bevacizumab and bortezomib
Study Details
This is a single-center (Emory University), open-label, single arm, phase I study to assess safety and toxicity of bortezomib in combination with bevacizumab and escalating doses of temozolomide for patients with recurrent glioblastoma multiforme. Patients requiring anti-epileptic medications will have to be at least 10 days off EIAEDs. Only non-EIAEDs are accepted.
Key Dates
- First listed
- Sep 16, 2011
- Start date
- Dec 31, 2011
- Status verified
- Apr 2016
- Primary completion
- Apr 30, 2016
- Completion
- Apr 30, 2016
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TherapyTherapy with temozolomide, bevacizumab and bortezomib
Primary Outcome Measure
Determination of progressive disease, complete or partial responses [ Time Frame: 6 weeks ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | - |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | - |
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