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Virus Therapy

Recurrent Malignant Glioma for Glioblastoma

Phase 1

Waitlist Available

Led By James Markert, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Patients must have normal organ and marrow function as defined below: leukocytes >3,000/ μl, absolute neutrophil count >1,500/ μl, platelets >100,000/ μl, total bilirubin within normal institutional limits, AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal, Creatinine within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

Age ≥18 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through month 12

Awards & highlights

Study Summary

This trial is studying a new drug called C134 to see if it is safe and well-tolerated when given directly into the brain where the tumor is.

Who is the study for?

This trial is for individuals with recurrent glioblastoma or similar brain tumors. Participants should have a tumor that has returned after previous treatment and be in good enough health to receive the experimental therapy directly into their brain.Check my eligibility

What is being tested?

The study is testing the safety and tolerability of an experimental drug called C134, which will be administered again directly to the site of the brain tumor.See study design

What are the potential side effects?

As this is an early-stage trial for C134, specific side effects are not listed but may include typical reactions related to brain procedures such as headache, nausea, seizures, or neurological changes.

Eligibility Criteria

Inclusion Criteria

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

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My blood tests show my organs are functioning well.

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I am 18 years old or older.

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I was treated with C134 over 4 weeks ago and my MRI shows my tumor has grown or falsely appeared to grow.

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I am able to care for myself and perform normal activities.

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My cancer is a confirmed aggressive brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through month 12 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Measure of Treatment-Emergent Adverse Events

Secondary outcome measures

Composition of the white blood cells

Measure Overall Survival

Measure interferon levels

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Recurrent Malignant GliomaExperimental Treatment1 Intervention

Participants that have completed the study "Trial of C134 in Patients With Recurrent GBM (C134-HSV-1)"

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,591 Previous Clinical Trials

2,281,653 Total Patients Enrolled

10 Trials studying Glioblastoma

255 Patients Enrolled for Glioblastoma

James Markert, MDPrincipal InvestigatorThe University of Alabama at Birmingham

2 Previous Clinical Trials

52 Total Patients Enrolled

2 Trials studying Glioblastoma

52 Patients Enrolled for Glioblastoma

Frequently Asked Questions

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

Are researchers currently seeking participants for this study?

"According to the data available on clinicaltrials.gov, this specific study is not currently accepting new participants. The trial was initially posted on January 1st, 2024 and the most recent update occurred on December 20th, 2023. However, it's worth noting that there are currently 1536 other active trials actively seeking individuals for participation at this time."

Answered by AI

Has the FDA granted approval for the treatment of recurrent malignant glioma?

"Given that this trial is in Phase 1, the safety rating for Recurrent Malignant Glioma is estimated to be at level 1. This indicates limited available data on both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Re-Administration of C134 in Patients With Recurrent GBM (C134-HSV-1)

James Markert, MD 2025. "Re-Administration of C134 in Patients With Recurrent GBM (C134-HSV-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06193174.

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