A Phase II Protocol for the Use of Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme
At present there are no satisfactory therapies for these patients with recurrent GBM and the
practitioner is left with best effort combination therapy for this disease. At present a
number of chemotherapeutic agents, including nitrosoureas, carboplatin, bevacizumab,
etoposide, irinotecan, and imatinib, have been used as salvage therapy either alone or in
combination. Additional trials with a variety of agents are underway, but preliminary
results from single-agent studies have been disappointing. Currently, only nitrosoureas
(lomustine and carmustine), including Gliadel® Wafer (carmustine) as adjunct to surgery, are
approved for use in previously treated GBM. At present the treatment of recurrent disease
with any available agent results in median survival in the ranges of 22-44 weeks. The
historical data from previous human exposure with Neuradiab is highly suggestive of a
benefit to patient survival.
Since Neuradiab® has shown promising efficacy in patients with recurrent disease with
acceptable risk-benefit ratio, and since there is no substantial survival benefit from
currently available agents used to treat this patient population, Neuradiab® is being
proposed as an experimental alternative to recurrent GBM patients under a Single-Center
Phase II Trial. Recurrent GBM is a serious and immediately life-threatening disease, for
which there is no comparable or satisfactory alternative drug or other therapy available to
treat that stage of the disease. Overall, survival data indicate a need for more effective
treatments for recurrent GBM.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The safety of Neuradiab® when followed by Avastin therapy will be assessed based on Investigator reported symptomatic toxicity findings on physical exam, and Adverse Events.
One year
No
David A. Reardon, MD
Principal Investigator
The Preston Robert Tisch Brain Tumor Center
United States: Food and Drug Administration
BRAD-302
NCT00906516
May 2009
December 2010
Name | Location |
---|---|
The Preston Robert Tisch Brain Tumor Center | Durham, North Carolina 27710 |