Brain TumorsPhase 2NCT00906516
Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme
A Phase 2 study testing Neuradiab in combination with Bevacizumab (Avastin) in people with Brain Tumors, run by Bradmer Pharmaceuticals Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors
- What is being tested?
- Neuradiab in combination with Bevacizumab (Avastin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Preston Robert Tisch Brain Tumor Center
Durham, North Carolina, 27710
David A. Reardon, MD, 919-668-1409, reard003@mc.duke.edu
Susan T. Boulton, RN, BSN, (919) 668-0896, boult001@mc.duke.edu
About this study
Official title: A Phase II Protocol for the Use of Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme
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.
Read the 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
- Being tested
- Neuradiab in combination with Bevacizumab (Avastin)
- Keywords
- Recurrent Glioblastoma multiforme (GBM), Recurrent Brain Tumor, Recurrent Brain Disease, Neuradiab, Avastin, Bevacizumab
- Medical subject headings
- Brain Neoplasms, Glioblastoma, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuradiab in combination with Bevacizumab (Avastin)Drug
Also called 131I-labeled anti-tenascin murine monoclonal antibody;, Bevacizumab
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Neuradiab in combination with Bevacizumab (Avastin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (2)
Overall survival (OS). Data will be reported based on a dataset of 60 patients.
Measured: One year
Time to progression (TTP). Data will be reported based on a dataset of 60 patients.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradmer Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David A. Reardon, MD, Principal investigator, The Preston Robert Tisch Brain Tumor Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906516
- Sponsor's protocol ID
- BRAD-302
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Protocol for the Use of Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00906516
- Acronym / sponsor ID
- BRAD-302
- Conditions
- Brain Tumors
- Keywords
- Recurrent Glioblastoma multiforme (GBM), Recurrent Brain Tumor, Recurrent Brain Disease, Neuradiab, Avastin, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bradmer Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuradiab in combination with Avastin | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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%.
Key exclusion criteria (17 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuradiab in combination with Bevacizumab (Avastin)Also: 131I-labeled anti-tenascin murine monoclonal antibody;, BevacizumabPatients 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 Avastin |
Primary outcome
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
2 secondary outcomes
Overall survival (OS). Data will be reported based on a dataset of 60 patients.
Time frame: One year
Time to progression (TTP). Data will be reported based on a dataset of 60 patients.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Reardon, MD principal investigator
The Preston Robert Tisch Brain Tumor Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neuradiab in combination with Bevacizumab (Avastin) in people with Brain Tumors, run by Bradmer Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David A. Reardon, MD (919-668-1409, reard003@mc.duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2009.