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Virus Therapy
C134 Virus Therapy for Glioblastoma (C134-HSV-1 Trial)
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through month 12
Awards & highlights
C134-HSV-1 Trial 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.Check my eligibility
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.See study design
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.
C134-HSV-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
C134-HSV-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through month 12
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 [Safety and Tolerability]
Secondary outcome measures
Leukocytes
Measure Overall Survival
Measure interferon levels
+2 moreC134-HSV-1 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
1,588 Previous Clinical Trials
2,280,288 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,661 Previous Clinical Trials
40,924,369 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,546 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer affects areas that need targeted treatment.My organ and bone marrow functions are normal.I am currently taking medication for herpes.I do not have any uncontrolled illnesses.My diagnosis is a type of aggressive brain tumor.My previous brain radiotherapy was unsuccessful, and it was over 4 weeks ago.I am 18 years old or older.My remaining tumor is between 1.0 and 5.5 cm and hasn't spread across both sides of my brain.I have never received experimental viral therapy.I am taking steroids, but within the allowed dose.I have had certain brain or nerve conditions in the past.I currently have an active cold sore.I haven't had chemotherapy, immunotherapy, or gene therapy in the last 6 weeks.I am able to care for myself but may not be able to do active work.I had surgery for my condition less than 4 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: C134 Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollments still open for this research project?
"As it stands, this clinical trial is not accepting participants. The study was initially posted on September 23rd 2019 and the latest update to its information occurred on September 19th 2022. Although the current situation does not support enrollment for this particular experiment, 467 other medical trials are actively looking for patients right now."
Answered by AI
What potential harms might be associated with exposure to C134?
"Our team at Power have assigned C134 a score of 1 on the safety scale owing to its Phase 1 trial status and thus limited evidence in support of efficacy and security."
Answered by AI
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