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Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation

This study has been terminated.
(AMAG not continuing with Combidex, the study drug)
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00659334
First received: April 10, 2008
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
Results First Received: May 15, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Brain Neoplasms
Interventions: Drug: Ferumoxtran-10 (Combidex)
Procedure: Neurosurgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Combidex Only (Group 1) Adults with brain tumor to receive Combidex infusion only
Combidex and Neurosurgery (Group 2) Adults with brain tumors to receive Combidex infusion and neurosurgery
Neurosurgery Only (Group 3) Adults with brain tumors to receive neurosurgery only (NO Combidex)
Combidex Only (Group 4) Children with brain tumors to receive Combidex only
Combidex and Neurosurgery (Group 5) Children with brain tumors to receive Combidex and neurosurgery
Neurosurgery Only (Group 6) Children with brain tumors to receive neurosurgery only, NO Combidex
Inflammatory Lesions (Group 7) Adults with Inflammatory lesions (stroke or MS) to receive Combidex only

Participant Flow:   Overall Study
    Combidex Only (Group 1)     Combidex and Neurosurgery (Group 2)     Neurosurgery Only (Group 3)     Combidex Only (Group 4)     Combidex and Neurosurgery (Group 5)     Neurosurgery Only (Group 6)     Inflammatory Lesions (Group 7)  
STARTED     46     41     5     2     1     0     21  
COMPLETED     38 [1]   36 [2]   5     2     1     0     20 [3]
NOT COMPLETED     8     5     0     0     0     0     1  
Screen Failure                 8                 5                 0                 0                 0                 0                 1  
[1] 8 Screen failures
[2] 5 Screen failures
[3] 1 screen failure



  Baseline Characteristics
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Reporting Groups
  Description
Combidex Only (Group 1) Adults with brain tumor to receive Combidex infusion only
Combidex and Neurosurgery (Group 2) Adults with brain tumors to receive Combidex infusion and neurosurgery
Neurosurgery Only (Group 3) Adults with brain tumors to receive neurosurgery only (NO Combidex)
Combidex Only (Group 4) Children with brain tumors to receive Combidex only
Combidex and Neurosurgery (Group 5) Children with brain tumors to receive Combidex and neurosurgery
Neurosurgery Only (Group 6) Children with brain tumors to receive neurosurgery only, NO Combidex
Inflammatory Lesions (Group 7) Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
Total Total of all reporting groups

Baseline Measures
    Combidex Only (Group 1)     Combidex and Neurosurgery (Group 2)     Neurosurgery Only (Group 3)     Combidex Only (Group 4)     Combidex and Neurosurgery (Group 5)     Neurosurgery Only (Group 6)     Inflammatory Lesions (Group 7)     Total  
Number of Participants  
[units: participants]
 		  46     41     5     2     1     0     21     116  
Age  
[units: participants]
 		               
<=18 years     0     0     0     2     1         0     3  
Between 18 and 65 years     37     35     5     0     0         19     96  
>=65 years     9     6     0     0     0         2     17  
Age  
[units: years]
Mean ± Standard Deviation 		  52.3  ± 13.2     48.4  ± 12.8     45.4  ± 14.2     14.7  ± 1.4     14.1  ± 0         43.0  ± 15.3     48.8  ± 15.1  
Gender  
[units: participants]
 		               
Female     21     17     2     1     1         8     50  
Male     25     24     3     1     0         13     66  
Region of Enrollment  
[units: participants]
 		               
United States     46     41     5     2     1         21     116  



  Outcome Measures

1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  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.   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early trial termination due to study drug Combidex no longer manufactured.  


Results Point of Contact:  
Name/Title: Dr. Edward Neuwelt
Organization: OHSU Knight Cancer Institute
phone: 503-494-5626
e-mail: neuwelte@ohsu.edu


No publications provided


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00659334     History of Changes
Other Study ID Numbers: OHSU-1127, 5R01NS034608
Study First Received: April 10, 2008
Results First Received: May 15, 2012
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration