NCT00906516

Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme

A Phase II Protocol for the Use of Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Bradmer Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bradmer Pharmaceuticals, Inc. (Bradmer) is requesting approval to study the safety of Neuradiab® when combined with Bevacizumab (Avastin) therapy given at a minimum of 30 days after Neuradiab administration in patients with a first or second recurrence of glioblastoma multiforme (GBM), in an attempt to manage life threatening recurrence of Grade IV malignant glioma.

Detailed description

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.

Conditions

• Brain Tumors

Interventions

Type	Name	Description
DRUG	Neuradiab in combination with Bevacizumab (Avastin)	Patients will be treated following surgical removal of recurrent glioblastoma with a single intracavitary dose of Neuradiab® delivering 44 Gy±10% to the ridge of the surgically created resection cavity followed by therapy with Bevacizumab (Avastin) at a minimum of 30 days after Neuradiab administration. Treatment with Bevacizumab will consist of 10mg/kg iv on days 1 and 15 every 28 days. Other chemotherapies (in addition to Avastin) will be permitted based on most current clinical practice and clinical evaluation of the patient.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2009-05-21
• Last updated: 2009-05-21

Locations

1 site across 1 country: United States