MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy
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| ClinicalTrials.gov Identifier: NCT00660543 |
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Recruitment Status :
Completed
First Posted : April 17, 2008
Results First Posted : May 16, 2016
Last Update Posted : May 16, 2017
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Sponsor:
OHSU Knight Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Neuwelt, OHSU Knight Cancer Institute
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Brief Summary:
This pilot clinical trial studies how a magnetic resonance imaging (MRI) study with ferumoxytol works as a contrasting agent in assessing early response in patients with glioblastoma multiforme receiving temozolomide and radiation therapy. Ferumoxytol is a very small form of iron particles that are injected into the body and taken up by certain tissues which may make these tissues easier to see during imaging. Diagnostic procedures, such as an MRI study with ferumoxytol, may help measure a patient's response to earlier treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adult Brain Glioblastoma | Drug: Gadolinium Drug: Ferumoxytol Non-Stoichiometric Magnetite Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Other: Diffusion Weighted Imaging Other: MRI-Based Angiogram | Not Applicable |
PRIMARY OBJECTIVES:
I. To characterize glioblastoma multiforme (GBM) tumor vascular properties using ferumoxytol (ferumoxytol non-stoichiometric magnetite) and compare to those obtained using gadolinium (Gd) based MRI contrast agent.
II. To characterize vascular changes in GBM tumors associated with standard radio/chemotherapy.
SECONDARY OBJECTIVES:
I. Cerebral blood flow (CBF), mean transit time (MTT), and time-to-peak (TTP) perfusion parameters will be measured for each contrast agent and evaluated in post-hoc analysis.
II. To obtain qualitative assessment of tumor vascularity using time-of-flight (TOF) magnetic resonance (MR) angiography techniques.
III. To characterize changes in the apparent diffusion coefficient (ADC) of tumor water associated with standard radio/chemotherapy in GBM.
OUTLINE:
Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo dynamic susceptibility contrast enhanced (DSC) MRI, and dynamic contrast enhanced (DCE) MRI, diffusion-weighted imaging (DWI) (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. Patients also receive temozolomide and undergo radiation therapy per standard of care.
After completion of ferumoxytol non-stoichiometric magnetite administration, patients are followed up for 4-6 weeks and then periodically until the resolution or stabilization of unacceptable toxicities.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Early Assessment of Tumor Response to Therapy Using Ferumoxytol (Code 7228) as an MR Contrast Agent in Patients With Glioblastoma Multiforme (MedDRA Code 10018337) |
| Study Start Date : | December 2006 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | June 2014 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ferumoxytol
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ferumoxytol
Patients receive ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity.
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Drug: Ferumoxytol Non-Stoichiometric Magnetite
Given IV
Other Names:
Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Undergo DCE MRI
Other Names:
Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Undergo DSC MRI
Other Names:
Other: Diffusion Weighted Imaging Undergo DWI
Other Names:
Other: MRI-Based Angiogram Undergo TOF MR angiography
Other Names:
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Active Comparator: Gadoteridol
Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
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Drug: Gadolinium
Given IV
Other Name: Gd Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Undergo DCE MRI
Other Names:
Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Undergo DSC MRI
Other Names:
Other: Diffusion Weighted Imaging Undergo DWI
Other Names:
Other: MRI-Based Angiogram Undergo TOF MR angiography
Other Names:
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Active Comparator: Gadoteridol Leakage Corrected
Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
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Drug: Gadolinium
Given IV
Other Name: Gd Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Undergo DCE MRI
Other Names:
Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Undergo DSC MRI
Other Names:
Other: Diffusion Weighted Imaging Undergo DWI
Other Names:
Other: MRI-Based Angiogram Undergo TOF MR angiography
Other Names:
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Primary Outcome Measures :
- Mean Cerebral Blood Volume (CBV) [ Time Frame: At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation) ]Radiographical progression is determined based on RANO criteria.
- Tumor Progression on Conventional MR [ Time Frame: Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation. ]Tumor progression was assessed by RANO criteria (Wen, 2010).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have radiologically and histologically confirmed diagnosis of glioblastoma multiforme
- Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter and visible on both axial and sagittal or coronal views
- Life expectancy of greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
- Patients scheduled for standard therapy (6 weeks radiation therapy (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week [w] RT, and followed routine monthly temozolomide therapy)
- Patients must be on a stable or decreasing dose (up to 8 mg daily) of dexamethasone throughout the study
- After entry into the study, patients are expected to be followed for at least 1 month after the last infusion of ferumoxytol
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol: parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2005); patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
- Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
- Patients who require monitored anesthesia for MRI scanning
- Patients with history of hemochromatosis or iron overload
- Patients with renal insufficiency (glomerular filtration rate (GFR) < 50)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ferumoxytol
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660543
Locations
| United States, Oregon | |
| OHSU Knight Cancer Institute | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Edward Neuwelt | OHSU Knight Cancer Institute |
| Responsible Party: | Edward Neuwelt, Professor, OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00660543 |
| Other Study ID Numbers: |
IRB00002753 NCI-2015-00224 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) SOL-06062-LX 813 NCI-2015-00204 8097 2753 ( Other Identifier: OHSU Knight Cancer Institute ) P30CA069533 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 17, 2008 Key Record Dates |
| Results First Posted: | May 16, 2016 |
| Last Update Posted: | May 16, 2017 |
| Last Verified: | April 2017 |
Additional relevant MeSH terms:
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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Ferrosoferric Oxide Hematinics Parenteral Nutrition Solutions Pharmaceutical Solutions |