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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Bradmer Pharmaceuticals Inc.
Study ID
NCT00906516
Phase
PHASE2
Status
Unknown

Conditions

  • Brain Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neuradiab in combination with Bevacizumab (Avastin) — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 21, 2009
Start date
May 31, 2009
Status verified
May 2009
Primary completion
Sep 30, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neuradiab in combination with 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.

Primary Outcome Measure

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. [ Time Frame: One year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Preston Robert Tisch Brain Tumor CenterDurhamNorth Carolina27710
David A. Reardon, MD
[email protected]
919-668-1409
Susan T. Boulton, RN, BSN
[email protected]
(919) 668-0896
David A. Reardon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By research site
The Preston Robert Tisch Brain Tumor Center· Durham, NC

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