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

12 Participants Needed

Trial Summary

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 re-administered into the brain where the tumor is located.

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.

What data supports the effectiveness of the treatment C134 for brain tumors?

The research articles suggest that re-irradiation and repeat surgery can improve survival outcomes for patients with recurrent glioblastoma, a type of brain tumor. This implies that using multiple treatment approaches, like C134, might be beneficial for similar conditions. ^{1 2 3 4 5}

How is the treatment C134 unique for brain tumors?

The treatment C134 is unique because it involves re-administration, which suggests it may be designed for repeated use in treating brain tumors, potentially offering a novel approach compared to standard treatments that may not focus on re-administration. ^{4 6 7 8 9}

Research Team

James Markert, MD

Principal Investigator

The University of Alabama at Birmingham

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Prognostic evaluations of recurrent gliomas and preliminary efficacies of combined modality therapy]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Favorable prognosis in patients with high-grade glioma with radiation necrosis: the University of Colorado reoperation series. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Surgical outcomes in recurrent glioma: clinical article. [2013]

4. Italy pubmed.ncbi.nlm.nih.gov

Re-irradiation of recurrent glioblastoma as part of a sequential multimodality treatment concept. [2020]

5. India pubmed.ncbi.nlm.nih.gov

The Impact of Surgery on the Survival of Patients with Recurrent Glioblastoma. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot study of high-dose thiotepa and etoposide with autologous bone marrow rescue in children and young adults with recurrent CNS tumors. The Children's Cancer Group. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Temozolomide and Reirradiation in Recurrent Grade II Brain Glioma. [2022]

8. Greece pubmed.ncbi.nlm.nih.gov

Feasibility of Salvage Re-irradiation With Stereotactic Radiotherapy for Recurrent Glioma Using CyberKnife. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Results of nuclear medical, electroencephalographic, and angiographic examinations after brain tumor operations]. [2006]