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

NCT00906516 | Unknown Phase 2

• 1 other identifier: BRAD-302
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumors

Keywords

Recurrent Glioblastoma multiforme (GBM); Recurrent Brain Tumor; Recurrent Brain Disease; Neuradiab; Avastin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Overall survival (OS). Data will be reported based on a dataset of 60 patients.

  One year

• Time to progression (TTP). Data will be reported based on a dataset of 60 patients.

  One year

Study Arms (1)

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)

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.

Also known as: 131I-labeled anti-tenascin murine monoclonal antibody;, Bevacizumab

Neuradiab in combination with Avastin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous histopathology confirmed diagnosis of (World Health Organization \[WHO\] grade IV astrocytoma; (http://rad.usuhs.mil/rad/who/who2b.html)
• 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:
• Patient is eligible for or has undergone a gross total surgical resection of the tumor mass with a residual ridge ≤ 1cm
• A post-operative MRI will be obtained within 72 hours of resection and must show an adequate resection defined by ≤ 1 cm enhancement.
• No evidence of hemorrhage on the baseline MRI or CT scan other than those that are postoperative grade 1.
• Age ≥ 18 years of age at the time of study entry.
• Karnofsky Performance Status ≥ 70%.
• Adequate bone marrow function
• Adequate hepatic function
• Adequate renal function
• Patient must be HAMA negative prior to study entry
• Able to tolerate standard post operative management for GBM debulking including corticosteroid therapy
• An interval of at least 30 days from prior chemotherapy (6 weeks for nitrosoureas) or investigational agent unless the patient has recovered from all anticipated toxicities associated with that therapy
• Women of childbearing potential must have a negative pregnancy test (serum or urine).
• The patient must agree to use an effective contraceptive method

You may not qualify if:

• Infratentorial tumor, tumor with subependymal spread, multifocal tumor, tumor with ventricular communication, intraventricular tumor or tumor which is within one gyrus (approximately 1cm) of the motor/sensory strip, either of the speech centers, or exceeds beyond the cranial vault.
• Severe, active comorbidity, including any of the following:
• Unstable angina and/or congestive heart failure requiring hospitalization
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
• Known hepatic insufficiency resulting in clinical jaundice (excluding Gilbert's syndrome) and/or coagulation defects
• Known AIDS based upon current CDC definition
• Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy
• Active connective tissue disorders, such as lupus or scleroderma that, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity.
• History of severe allergic reaction to contrast media.
• Any serious medical condition or psychiatric illness unresponsive to medical intervention.
• Prior malignancy if active treatment was required during the previous 3 years (except for adequately treated basal cell or squamous cell skin cancer and prior GBM)
• Known hypersensitivity to murine proteins.
• Inability to undergo an MRI.

Sponsors & Collaborators

• Bradmer Pharmaceuticals Inc.: lead

Study Sites (1)

The Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, 27710, United States

Location

Related Links

• Sponsor Web Site

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma; Brain Diseases

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; 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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• David A. Reardon, MD

  The Preston Robert Tisch Brain Tumor Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A. Reardon, MD

CONTACT

919-668-1409; reard003@mc.duke.edu

Susan T. Boulton, RN, BSN

CONTACT

(919) 668-0896; boult001@mc.duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 21, 2009

Record last verified: 2009-05

Locations

US (1)