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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NS034608 | U.S. NIH Grant/Contract | View source | |
| OHSU-1127 | Other Identifier | OHSU IRB |
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AMAG not continuing with Combidex, the study drug
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Adults with brain tumor to receive Combidex infusion only |
|
| 2 | Active Comparator | Adults with brain tumors to receive Combidex infusion and neurosurgery |
|
| 3 | Other | Adults with brain tumors to receive neurosurgery only (NO Combidex) |
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| 4 | Active Comparator | Children with brain tumors to receive Combidex only |
|
| 5 | Active Comparator | Children with brain tumors to receive Combidex and neurosurgery |
|
| 6 | Other | Children with brain tumors to receive neurosurgery only, NO Combidex |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxtran-10 (Combidex) | Drug | 2.6 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours (some patients between 3 and 72 hours) after administration of Combidex |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue | 2 years | |
| Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward A Neuwelt, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
There are seven groups in the study. In Groups 1(adults) and 4(pediatric) subjects receive the Combidex infusion only. In Groups 2(adult) and 5(pediatrics) subjects receive Combidex and undergo neurosurgery. In Groups 3(adult) and 6(pediatric) subjects undergo surgery with tissue exam; and in Group 7(adult only) subjects with MS or stroke.
Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combidex Only (Group 1) | Adults with brain tumor to receive Combidex infusion only |
| FG001 | Combidex and Neurosurgery (Group 2) | Adults with brain tumors to receive Combidex infusion and neurosurgery |
| FG002 | Neurosurgery Only (Group 3) | Adults with brain tumors to receive neurosurgery only (NO Combidex) |
| FG003 | Combidex Only (Group 4) | Children with brain tumors to receive Combidex only |
| FG004 | Combidex and Neurosurgery (Group 5) | Children with brain tumors to receive Combidex and neurosurgery |
| FG005 | Neurosurgery Only (Group 6) | Children with brain tumors to receive neurosurgery only, NO Combidex |
| FG006 | Inflammatory Lesions (Group 7) | Adults with Inflammatory lesions (stroke or MS) to receive Combidex only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No eligible individuals were identified to enroll in Group 6.
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| ID | Title | Description |
|---|---|---|
| BG000 | Combidex Only (Group 1) | Adults with brain tumor to receive Combidex infusion only |
| BG001 | Combidex and Neurosurgery (Group 2) | Adults with brain tumors to receive Combidex infusion and neurosurgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No eligible participants were identified to enroll in Group 6. Data not collected for Group 3 due to early study termination. | Posted | Number | Participants | 24 hours (some patients between 3 and 72 hours) after administration of Combidex |
|
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Other adverse events were collected/assessed, but none affected over 5% of the patient population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combidex Only (Group 1) | Adults with brain tumor to receive Combidex infusion only |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease Progression | Nervous system disorders |
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Early trial termination due to study drug Combidex no longer manufactured.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edward Neuwelt | OHSU Knight Cancer Institute | 503-494-5626 | neuwelte@ohsu.edu |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C097921 | ferumoxtran-10 |
| D019635 | Neurosurgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| 7 | Active Comparator | Adults with Inflammatory lesions (stroke or MS) to receive Combidex only |
|
| Neurosurgery | Procedure | 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. |
|
| 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. | 2 years |
| BG002 | Neurosurgery Only (Group 3) | Adults with brain tumors to receive neurosurgery only (NO Combidex) |
| BG003 | Combidex Only (Group 4) | Children with brain tumors to receive Combidex only |
| BG004 | Combidex and Neurosurgery (Group 5) | Children with brain tumors to receive Combidex and neurosurgery |
| BG005 | Neurosurgery Only (Group 6) | Children with brain tumors to receive neurosurgery only, NO Combidex |
| BG006 | Inflammatory Lesions (Group 7) | Adults with Inflammatory lesions (stroke or MS) to receive Combidex only |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Adults with brain tumor to receive Combidex infusion only
| OG001 | Combidex and Neurosurgery (Group 2) | Adults with brain tumors to receive Combidex infusion and neurosurgery |
| OG002 | Neurosurgery Only (Group 3) | Adults with brain tumors to receive neurosurgery only (NO Combidex) |
| OG003 | Combidex Only (Group 4) | Children with brain tumors to receive Combidex only |
| OG004 | Combidex and Neurosurgery (Group 5) | Children with brain tumors to receive Combidex and neurosurgery |
| OG005 | Neurosurgery Only (Group 6) | Children with brain tumors to receive neurosurgery only, NO Combidex |
| OG006 | Inflammatory Lesions (Group 7) | Adults with Inflammatory lesions (stroke or MS) to receive Combidex only |
|
|
| Secondary | Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue | Data was not collected due to early study termination (Combidex became obsolete with introduction of ferumoxytol and this study was closed early). | Posted | 2 years |
|
|
| Secondary | Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke. | Data was not collected due to early study termination (Combidex became obsolete with introduction of ferumoxytol and this study was closed early). | Posted | 2 years |
|
|
| Secondary | 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. | Data was not collected due to early study termination (Combidex became obsolete with introduction of ferumoxytol and this study was closed early). | Posted | 2 years |
|
|
| 10 |
| 46 |
| 0 |
| 46 |
| EG001 | Combidex and Neurosurgery (Group 2) | Adults with brain tumors to receive Combidex infusion and neurosurgery | 10 | 41 | 0 | 41 |
| EG002 | Neurosurgery Only (Group 3) | Adults with brain tumors to receive neurosurgery only (NO Combidex) | 2 | 5 | 0 | 5 |
| EG003 | Combidex Only (Group 4) | Children with brain tumors to receive Combidex only | 1 | 2 | 0 | 2 |
| EG004 | Combidex and Neurosurgery (Group 5) | Children with brain tumors to receive Combidex and neurosurgery | 0 | 1 | 0 | 1 |
| EG005 | Neurosurgery Only (Group 6) | Children with brain tumors to receive neurosurgery only, NO Combidex | 0 | 0 | 0 | 0 |
| EG006 | Inflammatory Lesions (Group 7) | Adults with Inflammatory lesions (stroke or MS) to receive Combidex only | 0 | 21 | 0 | 21 |
| Cerebellar Infraction | Nervous system disorders | Cerebellar infraction in the left hemisphere. |
|
| Post-Op Infection | Infections and infestations | Post-Op infection from craniotomy. |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |