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| Sponsor: | Bradmer Pharmaceuticals Inc. |
|---|---|
| Information provided by: | Bradmer Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00906516 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Tumors |
Drug: Neuradiab in combination with Bevacizumab (Avastin) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Control: Historical Control Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Protocol for the Use of Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Neuradiab in combination with Avastin: Experimental
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. |
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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with recurrent disease presenting as a supratentorial unifocal lesion seen on magnetic resonance imaging (MRI) suspicious for glioblastoma multiforme will be considered as long as:
Exclusion Criteria:
Severe, active comorbidity, including any of the following:
Contacts and Locations| Contact: David A. Reardon, MD | 919-668-1409 | reard003@mc.duke.edu |
| Contact: Susan T. Boulton, RN, BSN | (919) 668-0896 | boult001@mc.duke.edu |
| United States, North Carolina | |
| The Preston Robert Tisch Brain Tumor Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | David A. Reardon, MD | The Preston Robert Tisch Brain Tumor Center |
More Information
| Responsible Party: | The Preston Robert Tisch Brain Tumor Center ( David A. Reardon, MD ) |
| ClinicalTrials.gov Identifier: | NCT00906516 History of Changes |
| Other Study ID Numbers: | BRAD-302 |
| Study First Received: | May 19, 2009 |
| Last Updated: | May 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Recurrent Glioblastoma multiforme (GBM) Recurrent Brain Tumor Recurrent Brain Disease |
Neuradiab Avastin Bevacizumab |
|
Brain Neoplasms Glioblastoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Antibodies, Monoclonal Bevacizumab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Therapeutic Uses |