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Virus Therapy

C134 Re-Administration for Brain Tumors

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.
Must not have
Patients who have had chemotherapy, cytotoxic therapy, immunotherapy or gene therapy within 6 weeks prior to entering the study, surgical resection within 4 weeks prior to entering the study, or have received experimental viral therapy at any time (e.g., adenovirus, retrovirus or herpesvirus* protocol). Also, those who have not recovered from adverse events due to therapeutic interventions administered more than 4 weeks earlier.
Concurrent therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through month 12
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had certain cancer treatments or surgeries recently and have recovered from any side effects.
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I am not taking any medications for herpes.
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I have had severe allergic reactions to C134 or similar drugs.
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I do not have any severe illnesses or mental health issues that would prevent me from following the study's requirements.
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I am allergic to IV contrast and cannot be treated for it.
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I have never had encephalitis, multiple sclerosis, or any other CNS infection.
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I am not pregnant or breastfeeding.
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I currently have an active cold sore.
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My cancer affects areas in my brain that make treatment delivery complex.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure of Treatment-Emergent Adverse Events
Secondary study objectives
Composition of the white blood cells
Measure Overall Survival
Measure interferon levels
+2 more

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: Recurrent Malignant GliomaExperimental Treatment1 Intervention
Participants that have completed the study "Trial of C134 in Patients With Recurrent GBM (C134-HSV-1)"

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,704 Total Patients Enrolled
10 Trials studying Glioblastoma
245 Patients Enrolled for Glioblastoma
James Markert, MDPrincipal InvestigatorThe University of Alabama at Birmingham
2 Previous Clinical Trials
47 Total Patients Enrolled
2 Trials studying Glioblastoma
47 Patients Enrolled for Glioblastoma
~8 spots leftby Aug 2026
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