C134 Re-Administration for Brain Tumors

Overseen By Norma Miller, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Must not be taking: HSV drugs

Disqualifiers: Chemotherapy, Surgery, Large tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerance of a drug called C134 when administered again to individuals with recurring brain tumors. The focus is on conditions like glioblastoma multiforme, an aggressive type of brain cancer. Suitable candidates for this trial include those who previously tried C134 in an earlier study and experienced tumor recurrence or growth. Participants should have undergone specific radiation treatments beforehand. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot be on any drugs active against HSV (a type of virus) or other investigational therapeutic agents. If you are on steroids, your dose should not increase within 2 weeks of the C134 administration.

Is there any evidence suggesting that C134 is likely to be safe for humans?

Research shows that C134, a specially designed virus, targets and destroys cancer cells without harming healthy ones. Studies have found that it can multiply and break down cancer cells in the brain, particularly where the tumor's defenses are weak. In earlier research, C134 was tested for safety in people with brain tumors. The results suggested it is generally well-tolerated, although the study primarily focused on understanding its side effects. While the treatment remains in early trials, this phase primarily assesses initial safety, so participants should be aware that the full range of effects is still under exploration. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for recurrent malignant glioma, which often include surgery, radiation, and chemotherapy, C134 is unique because it utilizes a genetically modified virus. This treatment is derived from the herpes simplex virus (HSV-1) but is engineered to specifically target and kill cancer cells while sparing healthy tissue. Researchers are excited about C134 because this targeted approach could potentially offer a more effective treatment with fewer side effects compared to conventional therapies. By harnessing the virus's natural ability to spread through and destroy tumor cells, C134 may provide a novel way to combat aggressive brain tumors like glioblastomas.

What evidence suggests that C134 might be an effective treatment for brain tumors?

Research has shown that C134, the investigational treatment in this trial, might help fight brain tumors, such as recurrent malignant glioma. Studies have found that C134 can strengthen the body's immune system to attack tumors, potentially helping the immune system shrink the tumor. Early results suggest that C134 is safe when injected directly into the brain tumor. These findings are promising, but more research is needed to confirm its effectiveness. ^{1 5 6 7 8}

Who Is on the Research Team?

James Markert, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My blood tests show my organs are functioning well.

I agree to use birth control during and 6 months after the study due to unknown effects of C134.

I was treated with C134 over 4 weeks ago and my MRI shows my tumor has grown or falsely appeared to grow.

Exclusion Criteria

Patients may not be receiving any other investigational agents (except C134 per protocol).

Enhancing tumor diameter larger than 5.5 cm

I have had severe allergic reactions to C134 or similar drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive re-administration of C134 intratumorally to assess safety and tolerability

12 months

Multiple visits including pre-study, day 2, day 7, day 28, month 3, month 6, month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at month 3, month 6, and month 12

What Are the Treatments Tested in This Trial?

Interventions

• C134

Trial Overview

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.

How Is the Trial Designed?

Group I: Recurrent Malignant Glioma Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Salvage stereotactic radiotherapy (SRT) using CyberKnife for recurrent gliomas showed an acceptable safety profile, with only 11.4% of patients experiencing significant toxicity, specifically radiation-induced brain necrosis.

The treatment resulted in a median overall survival of 9 months and a progression-free survival of 3 months, indicating that SRT can be a viable option for patients with recurrent gliomas after initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Salvage Re-irradiation With Stereotactic Radiotherapy for Recurrent Glioma Using CyberKnife. Adachi, K., Hayashi, K., Kagawa, N., et al.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03657576

Trial of C134 in Patients With Recurrent GBM

A third study in 9 patients with recurrent malignant glioma was completed in which G207 was being administered followed by a single small dose of 5Gy of ...

2.

reporter.nih.gov

reporter.nih.gov/search/bMnLnWHxVkqVXI9eLHqzRw/project-details/9787387

Project Details - NIH RePORTER

We will test our hypothesis that “C134 is safe and induces immune activity that enhances the anti-tumor response in patients with recurrent malignant glioma” by ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8519502/

Immunovirotherapy for the Treatment of Glioblastoma and ...

The first clinical trial using reovirus in recurrent malignant glioma demonstrated that intratumoral injection was safe. Although the trial's purpose was not to ...

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trials.braintumor.org

trials.braintumor.org/trials/NCT06614855

A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296 ...

Search Results. A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296) Administered Intratumorally in Patients With Recurrent Malignant Glioma. Study Purpose.

5.

withpower.com

withpower.com/trial/phase-1-gliosarcoma-2024-54256

C134 Re-Administration for Brain Tumors

How Is the Trial Designed? 1Treatment groups. Experimental Treatment. Group I: Recurrent Malignant GliomaExperimental Treatment1 Intervention. Participants ...

6.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-00111

Genetically Engineered Virus (C134) for the Treatment of ...

This phase I trial identifies the side effects of C134 in treating patients with malignant glioma that has come back (recurrent). C134 is a genetically ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8310195/

Oncolytic Viruses for Malignant Glioma - PubMed Central - NIH

A phase I study is testing the safety of C134 in CNS tumors, including malignant glioma where the virus will be delivered into tumors (NCT03657576). Another ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S187887502402045X

Herpes Simplex Oncolytic Viral Therapy for Malignant ...

Kuo, et al. A phase 1 trial of oncolytic HSV-1, G207, given in combination with radiation for recurrent GBM demonstrates safety and radiographic responses.