C134 for Brain Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerance of a new experimental drug, C134, for treating certain types of brain tumors. All participants will receive the C134 treatment, administered directly to the tumor area in the brain. The trial aims to assess patient tolerance without using a placebo. It is suitable for individuals with specific brain tumors, such as recurrent glioblastoma, who have previously undergone radiation but still have a tumor. Participants must have a tumor at least 1 cm in diameter and should not have had recent chemotherapy or certain other treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
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.
Is there any evidence suggesting that the treatment C134 is likely to be safe for humans?
Research has shown that the investigational drug C134 appears to be safe. Animal studies tested C134 and found it safe, even in sensitive areas like the brain that are prone to infection. These tests help researchers predict how the treatment might work in humans.
In another study, researchers administered different doses of C134 to humans, focusing on safety. They aimed to assess how well people could tolerate the treatment, especially when delivered directly into brain tissue.
This is an early phase trial, one of the first steps to check the treatment's safety in humans. Early phase trials usually involve a small number of participants, allowing for close monitoring to ensure safety. This stage is crucial for identifying any potential side effects and ensuring the treatment does not cause harm.12345Why do researchers think this study treatment might be promising for brain tumors?
Unlike the standard treatments for brain tumors, such as surgery, radiation, and chemotherapy, IRS-1 HSV C134 introduces a novel approach by utilizing a genetically modified virus. This virus is designed to specifically target and destroy tumor cells, sparing healthy brain tissue. Researchers are excited because this targeted method could potentially reduce side effects and improve precision in attacking the tumor, offering a fresh hope for better outcomes in brain tumor treatment. Additionally, the localized delivery method via stereotactic biopsy allows for direct application to the tumor, potentially enhancing the effectiveness of the treatment.
What evidence suggests that C134 might be an effective treatment for brain tumors?
Research has shown that IRS-1 HSV C134, the investigational treatment in this trial, uses a modified virus to attack brain tumors. In earlier studies, tumors in mice shrank after treatment with this type of virus. Another study found that a similar virus not only reduced tumor size but also extended the lifespan of mice. This method is part of a new research area that uses viruses to target and destroy cancer cells while sparing healthy cells. Early results suggest that IRS-1 HSV C134 could be a promising treatment for brain tumors, but further research is needed to confirm its effectiveness in humans.13678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Initial Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants receive the first dose of the study drug C134 administered intratumorally
Initial Treatment Follow-up
Participants are monitored for safety and effectiveness after the initial treatment
2nd Treatment Screening
Participants are assessed for eligibility for the second dose of treatment
2nd Treatment
Participants receive the second dose of the study drug C134 if eligible
2nd Treatment Follow-up
Participants are monitored for safety and effectiveness after the second treatment
Long-term Follow-up
Participants are monitored for long-term safety and survival outcomes
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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
Published Research Related to This Trial
Citations
Study Details | NCT03657576 | Trial of C134 in Patients ...
Martuza and colleagues demonstrated that tumors implanted in mice shrank following treatment with varying doses of this virus. Additional modified viruses based ...
The Current State of Oncolytic Herpes Simplex Virus for ...
OHSVULBP3 inhibited tumor growth and prolonged median survival (18 days) compared to unarmed oHSV (8 days).
A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296 ...
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 ...
C134 for Brain Tumors · Info for Participants
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 ...
Herpes Simplex Oncolytic Viral Therapy for Malignant ...
The authors present a comprehensive review on the history and development of oncolytic herpes simplex viral therapies for malignant glioma
Pre-clinical Assessment of C134, a Chimeric Oncolytic ...
Here we present data demonstrating the safety of C134, a chimeric oHSV construct, in CBA mice as well as in a limited number of the HSV-sensitive non-human ...
Chimeric HCMV/HSV-1 and Δγ134.5 oncolytic herpes ...
It remains safe in the CNS environment by inducing early IFN signaling which restricts its replication in non-malignant cells. We sought to identify how C134 ...
A Phase I Trial of IRS-1 HSV C134 (IND 17296) ...
HSV1716 injection into the brain adjacent to tumour following surgical resection of high-grade glioma: safety data and long-term survival.
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