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

NCT00659334 | Terminated Phase 2 Results DMC

• 3 other identifiers: IRB000011275R01NS034608OHSU-1127
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Neoplasms

Keywords

Combidex; Diagnostic imaging

Outcome Measures

Primary Outcomes (1)

• 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

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

  2 years

• Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.

  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

Study Arms (7)

1

ACTIVE COMPARATOR

Adults with brain tumor to receive Combidex infusion only

Drug: Ferumoxtran-10 (Combidex)

2

ACTIVE COMPARATOR

Adults with brain tumors to receive Combidex infusion and neurosurgery

Drug: Ferumoxtran-10 (Combidex); Procedure: Neurosurgery

3

OTHER

Adults with brain tumors to receive neurosurgery only (NO Combidex)

Procedure: Neurosurgery

4

ACTIVE COMPARATOR

Children with brain tumors to receive Combidex only

Drug: Ferumoxtran-10 (Combidex)

5

ACTIVE COMPARATOR

Children with brain tumors to receive Combidex and neurosurgery

Drug: Ferumoxtran-10 (Combidex); Procedure: Neurosurgery

6

OTHER

Children with brain tumors to receive neurosurgery only, NO Combidex

Procedure: Neurosurgery

7

ACTIVE COMPARATOR

Adults with Inflammatory lesions (stroke or MS) to receive Combidex only

Drug: Ferumoxtran-10 (Combidex)

Interventions

Ferumoxtran-10 (Combidex) DRUG

2.6 mg/kg

Also known as: Combidex

1; 2; 4; 5; 7

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; 3; 5; 6

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Brain tumor or CNS inflammatory lesion including stroke or MS
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

ferumoxtran-10; Neurosurgical Procedures

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

Early trial termination due to study drug Combidex no longer manufactured.

Results Point of Contact

• Title: Dr. Edward Neuwelt
• Organization: OHSU Knight Cancer Institute

neuwelte@ohsu.edu

503-494-5626

Study Officials

• Edward A Neuwelt, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: August 1, 2000
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 21, 2022
• Results First Posted: November 9, 2012

Record last verified: 2022-11

Locations

US (1)