12 Participants Needed

C134 for Brain Tumors

JM
Overseen ByJames Markert, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take any drugs active against HSV (a type of virus) or any other investigational agents. If you're on steroids, your dose should not increase within 2 weeks before starting the trial, and it should ideally be equivalent to 2mg of dexamethasone daily.

What data supports the effectiveness of the treatment IRS-1 HSV C134 for brain tumors?

Research on similar treatments, like the oncolytic herpes simplex virus G207, shows promise in targeting brain tumors by safely inducing an immune response and increasing survival in animal models. Additionally, another oncolytic virus, HSV1716, has been shown to inhibit tumor migration and invasion, suggesting potential effectiveness in treating brain tumors.12345

Is the treatment C134 for brain tumors safe for humans?

Research on similar treatments, like HSV G207 and HSV1716, shows they are generally safe in humans, with no major toxicities reported. Some mild side effects like low-grade fever and chills were observed, but overall, these treatments have been well-tolerated in both adults and children.16789

How does the treatment IRS-1 HSV C134 for brain tumors differ from other treatments?

The treatment IRS-1 HSV C134 is unique because it is a chimeric oncolytic virus that combines elements from two viruses to enhance its ability to replicate in and destroy tumor cells without harming normal brain cells. This approach improves tumor reduction and survival in brain tumor models compared to other similar treatments.27101112

What is the purpose of this trial?

The purpose of this study is to determine how safe and how well-tolerated the experimental study drug, C134 is when administered twice into the brain where the tumor is located. This is a Phase IB 2 dosing study. All the patients who take part in this study will receive the same type of experimental treatment. There is no "placebo" in this study. The patient will receive the dose of C134 administered, which will be added in the tumor infiltrated tissue in the area of the resection cavity. Anywhere from 4-12 patients are expected to take part in the study; the final number will depend on the safety results.

Eligibility Criteria

This trial is for a small group of 4-12 patients with recurrent malignant glioma, which includes specific brain tumors like glioblastoma and astrocytoma. Participants must have a tumor that can be reached to administer the treatment directly.

Inclusion Criteria

Residual lesion must be ≥1.0 cm in diameter as determined by MRI
Patients must agree to use adequate contraception
My diagnosis is a type of aggressive brain tumor.
See 7 more

Exclusion Criteria

My tumor is larger than 5.5 cm.
I have had a condition where my lymphocytes grow abnormally.
I currently have an active cold sore.
See 12 more

Timeline

Initial Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive the first dose of the study drug C134 administered intratumorally

1 week
1 visit (in-person)

Initial Treatment Follow-up

Participants are monitored for safety and effectiveness after the initial treatment

4 weeks
2 visits (in-person)

2nd Treatment Screening

Participants are assessed for eligibility for the second dose of treatment

2 weeks

2nd Treatment

Participants receive the second dose of the study drug C134 if eligible

1 week
1 visit (in-person)

2nd Treatment Follow-up

Participants are monitored for safety and effectiveness after the second treatment

4 weeks
2 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and survival outcomes

12 months

Treatment Details

Interventions

  • IRS-1 HSV C134
Trial Overview The study is testing the safety and tolerability of an experimental drug called C134 when injected twice into the brain tissue where the tumor is located. There's no placebo; all participants receive the actual drug in their tumor infiltrated tissue.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Initial TreatmentExperimental Treatment1 Intervention
Patients will undergo a contrasted MRI scan to determine the site for stereotactic biopsy. For dose #1, patients will be treated under monitored local anesthesia, or at the surgeon's discretion, under general anesthesia. Patients will then undergo stereotactic biopsy of their tumor. While evidence of radiation damage or necrosis may be present on the frozen section, inoculation with C134 will only proceed if viable, recurrent glioma is also present on the frozen section. The dose level of C134 will be 1 x 105 plaque forming units (pfu). Virus will be inoculated via catheters placed stereotactically in enhancing regions of tumor or immediately adjacent in non-enhancing tumor infiltrated regions at up to 5 different loci (each injection over 2 minutes). Catheters will be removed directly after administration for treatment 1.
Group II: 2nd TreatmentExperimental Treatment1 Intervention
Before dose #2 administration, patients will undergo preoperative assessment of their disease status. If they are deemed to have had a complete response (CR), no treatment will be undertaken until there is evidence of a possible recurrence. If this does not occur until after week 16, the patient's situation will be discussed with the DSMB and a decision made about possible second treatment. If the patient has had a partial response or stable disease, and their tumor remains less than 5.5 cm in size, they wil lbe treated with stereotactic biopsy using the same technique described for dose #1 If the patient has suffered progression or peudoprogression, or if in the estimation of the surgeon it is not safe to perform inoculation alone, they will undergo craniotomy for resection of the tumor.

Find a Clinic Near You

Who Is Running the Clinical Trial?

James Markert, MD

Lead Sponsor

Trials
1
Recruited
10+

Findings from Research

A Phase 1 clinical trial is being conducted to evaluate the safety and tolerability of the oncolytic herpes simplex virus G207 combined with low-dose radiation in treating recurrent malignant pediatric cerebellar tumors, which are challenging to treat and often lead to poor outcomes.
The trial aims to not only assess safety but also to gather data on the efficacy of this treatment approach by monitoring tumor response, survival rates, and quality of life, potentially paving the way for more effective and less harmful therapies for children with brain tumors.
Design and Rationale for First-in-Human Phase 1 Immunovirotherapy Clinical Trial of Oncolytic HSV G207 to Treat Malignant Pediatric Cerebellar Brain Tumors.Bernstock, JD., Bag, AK., Fiveash, J., et al.[2021]
G207, a genetically engineered herpes simplex virus, was found to be non-toxic when administered to the cerebellum of mice, showing no harmful effects on brain or organ health after 7 and 30 days.
The treatment with G207 significantly increased survival rates in mice with aggressive MYC-overexpressed group 3 medulloblastoma, suggesting its potential as an effective therapy for children with difficult-to-treat cerebellar tumors.
Safety and efficacy of oncolytic HSV-1 G207 inoculated into the cerebellum of mice.Bernstock, JD., Vicario, N., Li, R., et al.[2021]
The oncolytic virus Delta-24-RGD has been shown to be safe and significantly increase survival in mouse models of pediatric high-grade glioma (pHGG) and diffuse intrinsic pontine gliomas (DIPGs), indicating its potential as a treatment option.
The therapeutic effect of Delta-24-RGD is attributed to both its ability to directly kill tumor cells and to stimulate an immune response against the tumors, leading to the initiation of a phase I/II clinical trial for newly diagnosed DIPG patients.
The oncolytic virus Delta-24-RGD elicits an antitumor effect in pediatric glioma and DIPG mouse models.Martínez-Vélez, N., Garcia-Moure, M., Marigil, M., et al.[2021]

References

Design and Rationale for First-in-Human Phase 1 Immunovirotherapy Clinical Trial of Oncolytic HSV G207 to Treat Malignant Pediatric Cerebellar Brain Tumors. [2021]
Oncolytic Herpes Simplex Virus Inhibits Pediatric Brain Tumor Migration and Invasion. [2021]
Safety and efficacy of oncolytic HSV-1 G207 inoculated into the cerebellum of mice. [2021]
Treatment of experimental intracranial murine melanoma with a neuroattenuated herpes simplex virus 1 mutant. [2023]
The oncolytic virus Delta-24-RGD elicits an antitumor effect in pediatric glioma and DIPG mouse models. [2021]
Replication-competent herpes simplex virus retargeted to HER2 as therapy for high-grade glioma. [2023]
HSV1716 injection into the brain adjacent to tumour following surgical resection of high-grade glioma: safety data and long-term survival. [2023]
Efficacy of HER2 retargeted herpes simplex virus as therapy for high-grade glioma in immunocompetent mice. [2014]
Intratumoral Injection of HSV1716, an Oncolytic Herpes Virus, Is Safe and Shows Evidence of Immune Response and Viral Replication in Young Cancer Patients. [2023]
Expression of inhibitor of growth 4 by HSV1716 improves oncolytic potency and enhances efficacy. [2022]
Enhanced antiglioma activity of chimeric HCMV/HSV-1 oncolytic viruses. [2012]
12.United Statespubmed.ncbi.nlm.nih.gov
Ultrastructural analysis of ICP34.5- herpes simplex virus 1 replication in mouse brain cells in vivo. [2021]
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