- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: David A. Reardon, MD
- Phone Number: 919-668-1409
- Email: reard003@mc.duke.edu
Study Contact Backup
- Name: Susan T. Boulton, RN, BSN
- Phone Number: (919) 668-0896
- Email: boult001@mc.duke.edu
Study Locations
-
-
North Carolina
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Durham, North Carolina, United States, 27710
- The Preston Robert Tisch Brain Tumor Center
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Contact:
- David A. Reardon, MD
- Phone Number: 919-668-1409
- Email: reard003@mc.duke.edu
-
Contact:
- Susan T. Boulton, RN, BSN
- Phone Number: (919) 668-0896
- Email: boult001@mc.duke.edu
-
Principal Investigator:
- David A. Reardon, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Patient must give written informed consent prior to any study-specific procedures being implemented
Exclusion Criteria:
- 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.
- Patient has been treated with any anti-angiogenic therapy within 30 days prior to study entry
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS). Data will be reported based on a dataset of 60 patients.
Time Frame: One year
|
One year
|
Time to progression (TTP). Data will be reported based on a dataset of 60 patients.
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David A. Reardon, MD, The Preston Robert Tisch Brain Tumor Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Glioblastoma
- Brain Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- BRAD-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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