Brain NeoplasmsPhase 2NCT00659334
Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation
A Phase 2 study testing Ferumoxtran-10 (Combidex) and Neurosurgery in people with Brain Neoplasms, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating. It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such as the liver and spleen and for imaging lymph nodes. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Ferumoxtran-10 (Combidex) and Neurosurgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Brain tumor or CNS inflammatory lesion including stroke or MS
- 5 yrs old or older
- Able to undergo MRI without general anesthesia
- Agree to be followed for 1 month following infusion of Combidex
- Sign a written informed consent
- If female and of child-bearing potential, be postmenopausal, sterile, or be on birth control for 1 month prior to study
- Must have a pre-treatment MRI within 28 days before study
Who cannot join
- Clinically significant signs of uncal herniation
- Allergy to study drug, Combidex
- Hepatic insufficiency
- Stage IV or V renal insufficiency
- If female, pregnant or lactating
- Require anesthesia for MRI scanning
- Hemachromatosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Multi-disciplinary Study: MR, Histologic and EM Imaging of Intravenous Superparamagnetic Crystalline Particles (Combidex) to Brain, Intra-cerebral Tumors and in CNS Inflammation
Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating. It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent to the tumor location. Combidex may provide the ability to better see brain tumors and inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its ability to cross blood vessels into brain tumors, and because of its size and ability to get into the area next to brain tumors, could assist in the treatment of brain tumors with other drugs in the future.
Read the detailed description
Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU. There are four groups of the study:
- Subjects receive the combidex infusion only.
- Subjects receive Combidex and undergo a previously schedule neurosurgery.
- Subjects undergo surgery only and provide a sample of their tumor tissue to be used in pathology studies of Combidex.
- Subjects with MS or stroke are invited to participate in receiving Combidex to evaluate the effectiveness of enhancing the area of damage within the brain.
Subjects are deemed eligible for the study and undergo a baseline MRI within 28 days of receiving Combidex. Subjects receiving Combidex are admitted for a half day into the Oregon Clinical \& Translational Research Institute(OCTRI). Combidex is infused I.V. over 30 minutes. Subjects are monitored for side effects and are discharged within about 5 hours after the infusion, if no complications have been noted. Subjects return 24 hours after the infusion for a post infusion MRI scan and return again to one of the neurology clinics for one month follow-up. Subjects enrolled in group 2 undergo surgery 1-2 days after the Combidex infusion and also undergo a 24 post infusion MRI and return for one month follow-up. These subjects are also followed closely by the neurosurgical physician during the course of follow-up. Subjects enrolled in group 3 only undergo surgery and agree to have a piece of their tumor resection or biopsy donated for use in the study. Group 4 is the same as group 1, except the patient population includes multiple sclerosis and stroke instead of patients with brain tumors.
- Conditions
- Brain Neoplasms
- Being tested
- Ferumoxtran-10 (Combidex), Neurosurgery
- Keywords
- Combidex, Diagnostic imaging
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxtran-10 (Combidex)Drug
Also called Combidex
2.6 mg/kg
NeurosurgeryProcedure or surgery
neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Adults with brain tumor to receive Combidex infusion only Receives: Drug: Ferumoxtran-10 (Combidex) |
| 2 | Active comparator | Adults with brain tumors to receive Combidex infusion and neurosurgery Receives: Drug: Ferumoxtran-10 (Combidex); Procedure: Neurosurgery |
| 3 | Other | Adults with brain tumors to receive neurosurgery only (NO Combidex) Receives: Procedure: Neurosurgery |
| 4 | Active comparator | Children with brain tumors to receive Combidex only Receives: Drug: Ferumoxtran-10 (Combidex) |
| 5 | Active comparator | Children with brain tumors to receive Combidex and neurosurgery Receives: Drug: Ferumoxtran-10 (Combidex); Procedure: Neurosurgery |
| 6 | Other | Children with brain tumors to receive neurosurgery only, NO Combidex Receives: Procedure: Neurosurgery |
| 7 | Active comparator | Adults with Inflammatory lesions (stroke or MS) to receive Combidex only Receives: Drug: Ferumoxtran-10 (Combidex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.
Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.
Measured: 24 hours (some patients between 3 and 72 hours) after administration of Combidex
Secondary outcomes (3)
Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue
Measured: 2 years
Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.
Measured: 2 years
Compare Pre- and Post-op Gd Enhanced MRI Combidex Enhanced MR Imaging Done Pre-, Intra- and Post-operatively, to Assess the Degree of Resection and Residual Tumor.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startAug 2000
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: AMAG not continuing with Combidex, the study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Edward Neuwelt, OHSU Knight Cancer Institute
- Investigators
- Edward A Neuwelt, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659334
- Sponsor's protocol ID
- IRB00001127
- Other IDs
- 5R01NS034608, OHSU-1127
- Status last verified
- Nov 2022
- First submitted
- 10 Apr 2008
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-disciplinary Study: MR, Histologic and EM Imaging of Intravenous Superparamagnetic Crystalline Particles (Combidex) to Brain, Intra-cerebral Tumors and in CNS Inflammation
- ClinicalTrials.gov ID
- NCT00659334
- Acronym / sponsor ID
- IRB00001127
- Conditions
- Brain Neoplasms
- Keywords
- Combidex, Diagnostic imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AMAG not continuing with Combidex, the study drug
- Enrolment
- 116 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2000
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 9 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating. It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent to the tumor location. Combidex may provide the ability to better see brain tumors and inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its ability to cross blood vessels into brain tumors, and because of its size and ability to get into the area next to brain tumors, could assist in the treatment of brain tumors with other drugs in the future.
Detailed description
Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU. There are four groups of the study:
- Subjects receive the combidex infusion only.
- Subjects receive Combidex and undergo a previously schedule neurosurgery.
- Subjects undergo surgery only and provide a sample of their tumor tissue to be used in pathology studies of Combidex.
- Subjects with MS or stroke are invited to participate in receiving Combidex to evaluate the effectiveness of enhancing the area of damage within the brain.
Subjects are deemed eligible for the study and undergo a baseline MRI within 28 days of receiving Combidex. Subjects receiving Combidex are admitted for a half day into the Oregon Clinical \& Translational Research Institute(OCTRI). Combidex is infused I.V. over 30 minutes. Subjects are monitored for side effects and are discharged within about 5 hours after the infusion, if no complications have been noted. Subjects return 24 hours after the infusion for a post infusion MRI scan and return again to one of the neurology clinics for one month follow-up. Subjects enrolled in group 2 undergo surgery 1-2 days after the Combidex infusion and also undergo a 24 post infusion MRI and return for one month follow-up. These subjects are also followed closely by the neurosurgical physician during the course of follow-up. Subjects enrolled in group 3 only undergo surgery and agree to have a piece of their tumor resection or biopsy donated for use in the study. Group 4 is the same as group 1, except the patient population includes multiple sclerosis and stroke instead of patients with brain tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ferumoxtran-10 (Combidex)Adults with brain tumor to receive Combidex infusion only |
| 2 | Active comparator | Drug: Ferumoxtran-10 (Combidex), Procedure: NeurosurgeryAdults with brain tumors to receive Combidex infusion and neurosurgery |
| 3 | Other | Procedure: NeurosurgeryAdults with brain tumors to receive neurosurgery only (NO Combidex) |
| 4 | Active comparator | Drug: Ferumoxtran-10 (Combidex)Children with brain tumors to receive Combidex only |
| 5 | Active comparator | Drug: Ferumoxtran-10 (Combidex), Procedure: NeurosurgeryChildren with brain tumors to receive Combidex and neurosurgery |
| 6 | Other | Procedure: NeurosurgeryChildren with brain tumors to receive neurosurgery only, NO Combidex |
| 7 | Active comparator | Drug: Ferumoxtran-10 (Combidex)Adults with Inflammatory lesions (stroke or MS) to receive Combidex only |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Brain tumor or CNS inflammatory lesion including stroke or MS
- 5 yrs old or older
- Able to undergo MRI without general anesthesia
- Agree to be followed for 1 month following infusion of Combidex
- Sign a written informed consent
Key exclusion criteria (7 listed)
- Clinically significant signs of uncal herniation
- Allergy to study drug, Combidex
- Hepatic insufficiency
- Stage IV or V renal insufficiency
- If female, pregnant or lactating
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 |
|---|---|---|
| Ferumoxtran-10 (Combidex)Also: Combidex2.6 mg/kg | Drug | 1, 2, 4, 5, 7 |
| Neurosurgeryneuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy. | Procedure or surgery | 2, 3, 5, 6 |
Primary outcome
Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.
Time frame: 24 hours (some patients between 3 and 72 hours) after administration of Combidex
Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.
3 secondary outcomes
Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue
Time frame: 2 years
Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.
Time frame: 2 years
Compare Pre- and Post-op Gd Enhanced MRI Combidex Enhanced MR Imaging Done Pre-, Intra- and Post-operatively, to Assess the Degree of Resection and Residual Tumor.
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Edward A Neuwelt, MD principal investigator
Oregon Health and Science University
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 Ferumoxtran-10 (Combidex) and Neurosurgery in people with Brain Neoplasms, run by OHSU Knight Cancer Institute 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 9 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex. (time frame: 24 hours (some patients between 3 and 72 hours) after administration of Combidex). 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 Dec 2022.