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Alkylating agents

Chemoradiation for Glioblastoma (NeoGlio Trial)

Phase 2
Recruiting
Led By Anand Mahadevan, M.D.
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status (KPS)>70
Newly diagnosed GBM with histopathological confirmation
Must not have
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months after completion of therapy
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for glioblastoma that has not been well studied before. The goal is to see if it improves local control, which is when the cancer comes back in the same area. If the new treatment is promising, there will be a bigger clinical trial testing it against the standard treatment.

Who is the study for?
This trial is for adults with newly diagnosed, resectable glioblastoma confirmed by pathology. Participants must be fit for surgery, have a Karnofsky Performance Status over 70 (meaning they are able to care for themselves), and have proper organ function including adequate blood counts and liver function. Pregnant women or those who could become pregnant must test negative and agree to use contraception.
What is being tested?
The study is testing the effectiveness of chemoradiation before surgery in patients with glioblastoma. It's a Phase II trial where participants will receive Temozolomide alongside radiation therapy prior to their tumor being surgically removed, comparing this approach against standard treatment protocols.
What are the potential side effects?
Potential side effects include fatigue, nausea, hair loss from radiation, low blood cell counts leading to increased infection risk or bleeding problems, liver issues indicated by altered blood tests, and possible allergic reactions to Temozolomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself but may not be able to do active work.
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I have been newly diagnosed with GBM confirmed by tissue analysis.
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I am considered a good candidate for major surgery to remove my tumor.
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I have been recently diagnosed with GBM confirmed by tissue analysis.
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I am a candidate for major surgery as reviewed.
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My liver tests are within normal limits.
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I can safely receive chemoradiation.
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I can safely receive chemoradiation.
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My recent blood test shows my bone marrow is working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant and willing to use birth control during the study.
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I am currently on IV antibiotics for a bacterial or fungal infection.
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I am on dialysis or have been advised to start it due to end-stage kidney disease.
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My brain tumor has come back, can't be removed, or is in multiple places.
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I do not have a severe lung condition that requires hospital care right now.
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My cancer has spread from its original location.
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I was hospitalized for heart failure within the last 3 months.
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I have not had a heart attack in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months after completion of therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months after completion of therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
No study related undue toxicity or progression in >6 of 11 patients.
Progression Free Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neoadjuvant chemoradiation and surgical resectionExperimental Treatment3 Interventions
The experimental part of the study would be this selection of resectable patients and sequencing neoadjuvant chemoradiation prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neoadjuvant chemoradiation
2011
Completed Phase 3
~60

Find a Location

Who is running the clinical trial?

Geisinger ClinicLead Sponsor
154 Previous Clinical Trials
1,978,656 Total Patients Enrolled
Anand Mahadevan, M.D.4.52 ReviewsPrincipal Investigator - Geisinger Clinic
Geisinger Clinic
1 Previous Clinical Trials
6 Total Patients Enrolled

Media Library

Temozolomide (benzolamide) (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04209790 — Phase 2
Glioblastoma Research Study Groups: Neoadjuvant chemoradiation and surgical resection
Glioblastoma Clinical Trial 2023: Temozolomide (benzolamide) Highlights & Side Effects. Trial Name: NCT04209790 — Phase 2
Temozolomide (benzolamide) (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209790 — Phase 2
~1 spots leftby Dec 2024
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