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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months after completion of therapy
Awards & highlights

NeoGlio Trial 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.Check my eligibility
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.See study design
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.

NeoGlio Trial 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.

NeoGlio Trial 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

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

NeoGlio 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
148 Previous Clinical Trials
1,886,063 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

Frequently Asked Questions

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

Has this therapeutic intervention been cleared by the Food and Drug Administration?

"Our team at Power judged the security of this treatment to be a 2 since it is still in Phase 2, which suggests that there are some safety data available but no evidence for efficacy."

Answered by AI

Have any other research initiatives been conducted exploring this therapeutic method?

"Currently, 207 clinical trials are actively investigating this medication with 24 of these investigations having progressed to Phase 3. Interestingly, there is a large concentration of studies based in Seoul and Songpa; however, there exist 4752 other locations running similar research."

Answered by AI

To what afflictions is this therapy normally administered?

"Nitrosourea treatment is the primary purpose of this medication, however it has also been successfully used to treat conditions such as advanced directives and refractory mycosis fungoides in addition torefractory neuroblastoma."

Answered by AI

Does this experiment accept participants over 30 years of age?

"As per the inclusion criteria, those between 18 and 89 years of age are eligible to join this trial. 126 trials cater specifically for minors while 828 studies target seniors past 65."

Answered by AI

Are there any opportunities for me to participate in this research initiative?

"The current trial has a recruitment target of 30 glioblastoma patients aged between 18 and 89. To qualify, these individuals should be deemed suitable for subtotal or gross resection by central review, with no contraindications to chemoradiation therapy."

Answered by AI

What is the current enrollment threshold for this research?

"Affirmative. The details available on clinicaltrials.gov demonstrate that this research trial, which was first posted April 1st 2020, is currently seeking volunteers. Approximately 30 participants need to be sourced from 2 separate medical centers."

Answered by AI

Does this trial mark a breakthrough in its field?

"Worldwide, 207 active clinical trials are ongoing for this specific treatment. These studies span 935 cities and 36 nations, beginning in 2002 when Schering-Plough conducted a Phase 2 trial involving 60 participants. From that point onward, 296 additional tests have been administered."

Answered by AI

Are there currently spots open for this clinical trial?

"Per the data hosted on clinicaltrials.gov, this health study is currently recruiting patients. It was first listed in April 2020 and its information was most recently updated at the end of January 2022."

Answered by AI
Recent research and studies
~6 spots leftby Apr 2025