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Monoclonal Antibodies

Ferumoxytol MRI for Pembrolizumab Response in Glioblastoma

Phase 2

Waitlist Available

Led By Prakash Ambady, MD

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a histologically confirmed diagnosis of newly diagnosed glioblastoma (World Health Organization [WHO] grade IV)

Subject is eligible for and agrees to receive standard of care radiation and temozolomide after biopsy or maximum safe surgical resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether ferumoxytol MRI can show how well pembrolizumab is working in patients with glioblastoma.

Who is the study for?

This trial is for adults with newly diagnosed glioblastoma who can consent, have a life expectancy of at least 6 months, and meet specific health criteria like adequate blood counts and organ function. They must not be pregnant or breastfeeding, agree to use birth control, and should not have certain allergies or immune conditions.Check my eligibility

What is being tested?

The trial is testing how well ferumoxytol-enhanced MRI works in assessing the response of glioblastoma patients to pembrolizumab treatment. It's a pilot phase II study that involves diagnostic procedures alongside standard cancer therapies.See study design

What are the potential side effects?

Potential side effects include reactions to ferumoxytol such as cramps, dizziness, nausea; pembrolizumab may cause immune-related issues like inflammation in organs, fatigue, skin problems, hormone gland problems (like thyroid), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of brain tumor called glioblastoma.

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I agree to undergo standard radiation and take temozolomide after my surgery or biopsy.

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I can care for myself and am on a stable or reducing dose of steroids, not exceeding 8 mg of dexamethasone daily, for the last 5 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity and specificity of ferumoxytol steady state imaging

Secondary outcome measures

Duration of best response

Overall survival

Progression free survival

+1 more

Other outcome measures

Changes in PD-L1 expression

Number and type of systemic and tumor infiltrating T cell

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (Ferumoxytol MRI, pembrolizumab)Experimental Treatment4 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferumoxytol

2011

Completed Phase 4

~4380

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER

973 Previous Clinical Trials

6,845,973 Total Patients Enrolled

1 Trials studying Glioblastoma

29 Patients Enrolled for Glioblastoma

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,670 Total Patients Enrolled

2 Trials studying Glioblastoma

43 Patients Enrolled for Glioblastoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,097 Total Patients Enrolled

322 Trials studying Glioblastoma

23,059 Patients Enrolled for Glioblastoma

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03347617 — Phase 2

Glioblastoma Research Study Groups: Diagnostic (Ferumoxytol MRI, pembrolizumab)

Glioblastoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03347617 — Phase 2

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03347617 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the government's stance on Pembrolizumab?

"Pembrolizumab has received a score of 2 for safety. This is because, although there is some evidence supporting its safety profile, there is no data attesting to its efficacy."

Answered by AI

What is the maximum number of people that can join this trial?

"This particular trial is no longer recruiting patients, as indicated by the clinicaltrials.gov posting from December 20th, 2017 (last edited June 9th, 2022). However, there are 1016 trials for Pembrolizumab and 458 trials for glioblastoma currently looking for participants."

Answered by AI

Could you please share if there is precedent for this type of treatment?

"Pembrolizumab is being trialled in 1016 clinical studies, 126 of which are currently ongoing. Most of the research for Pembrolizumab takes places in Houston, Texas; however, there are 36071 locations around the world running similar investigations."

Answered by AI

Are subjects being recruited for this research project at the moment?

"As can be seen on clinicaltrials.gov, this specific trial is not recruiting patients right now. This study was first posted on December 20th, 2017 and was most recently edited on June 9th, 2022. There are 1,474 other trials that are looking for volunteers as of today."

Answered by AI

What are the most popular conditions that Pembrolizumab is used to treat?

"Pembrolizumab is the go-to treatment for malignant neoplasms. However, it can also be used to treat other conditions such as unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma

Leslie Muldoon 2017. "Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03347617.

All > Recurrent Glioblastoma > Glioblastoma Multiforme