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Virus Therapy

C134 Virus Therapy for Glioblastoma (C134-HSV-1 Trial)

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
Normal organ and marrow function as defined
Patients must have histologically or cytologically confirmed recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma
Must not have
Concurrent therapy with drugs active against HSV
Uncontrolled intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through month 12
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a cancer-killing virus (HSV-1) that's been genetically engineered to be safe for humans. The goal is to see if it's effective at killing tumor cells and if it has any serious side effects.

Who is the study for?
This trial is for adults over 18 with recurrent brain tumors (glioblastoma, anaplastic astrocytoma, or gliosarcoma) who've had prior radiation therapy. They must have a life expectancy over 4 weeks and be in good health otherwise. Participants need to use birth control due to unknown effects on fetuses and agree not to join if they're pregnant, have increased their steroid dose recently, or are taking anti-HSV drugs.
What is being tested?
The trial tests C134, a genetically modified herpes virus designed to target and kill tumor cells while boosting the immune response against the tumor. Patients will receive increasing doses of C134 directly into their tumors using MRI guidance. The study also monitors how the body reacts to the virus and any changes in tumor size via MRI scans.
What are the potential side effects?
Potential side effects may include reactions at the injection site within the brain, flu-like symptoms due to immune response activation, fatigue from treatment stress on the body's systems, possible allergic reactions similar to other biological compounds like viruses used in gene therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organ and bone marrow functions are normal.
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My diagnosis is a type of aggressive brain tumor.
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I am 18 years old or older.
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My remaining tumor is between 1.0 and 5.5 cm and hasn't spread across both sides of my brain.
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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication for herpes.
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I do not have any uncontrolled illnesses.
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I have never received experimental viral therapy.
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My cancer affects areas that need targeted treatment.
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I have had certain brain or nerve conditions in the past.
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I currently have an active cold sore.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 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 [Safety and Tolerability]
Secondary study objectives
Leukocytes
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: C134 TreatmentExperimental Treatment1 Intervention
All patients who enroll will receive C134 inoculation into their tumor (one time procedure with 1-5 inoculation sites)

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,754 Total Patients Enrolled
10 Trials studying Glioblastoma
238 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,982 Total Patients Enrolled
330 Trials studying Glioblastoma
23,357 Patients Enrolled for Glioblastoma
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,468 Total Patients Enrolled
1 Trials studying Glioblastoma
90 Patients Enrolled for Glioblastoma

Media Library

C134 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03657576 — Phase 1
Glioblastoma Research Study Groups: C134 Treatment
Glioblastoma Clinical Trial 2023: C134 Highlights & Side Effects. Trial Name: NCT03657576 — Phase 1
C134 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03657576 — Phase 1
~1 spots leftby Apr 2025
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