Cerebraca Wafer + Temozolomide for Brain Cancer

(Cerebraca-02/3 Trial)

Overseen By Jen Wei Liu, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Everfront Biotech Co., Ltd.

Must be taking: Temozolomide

Must not be taking: Immunosuppressants

Disqualifiers: Oligodendroglioma, IDH mutation, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Cerebraca Wafer for individuals with recurrent glioblastoma, a type of brain cancer that returns after initial treatment. The study aims to determine if combining Cerebraca Wafer with the standard chemotherapy drug temozolomide can improve outcomes after surgery. Participants are divided into two groups: one receives the standard treatment, while the other receives Cerebraca Wafer in addition to the standard treatment. This trial suits those who have undergone surgery, radiation, and temozolomide, and whose brain cancer has returned once or twice. As a Phase 2 trial, it focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important research.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Cerebraca Wafer is safe for patients with recurring glioblastoma, a type of brain cancer. In studies, patients who received the highest dose of 6 Cerebraca Wafers experienced no drug-related side effects, indicating a positive safety profile. Additionally, some patients lived more than two years after treatment, which is very encouraging.

Temozolomide, a common treatment for brain cancer, is usually well-tolerated, with most people not experiencing serious side effects. Its frequent use has provided extensive knowledge about its safety.

In summary, both the Cerebraca Wafer and temozolomide have demonstrated safety, with no major safety issues reported so far. This makes them a potentially safe choice for patients considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for brain cancer?

Researchers are excited about the Cerebraca Wafer because it offers a novel approach to treating brain cancer. Unlike standard treatments that rely solely on oral chemotherapy like Temozolomide, the Cerebraca Wafer is implanted directly into the brain during surgery. This allows for a concentrated, localized dose of the active ingredient, (Z)-BP, right at the tumor site. This direct delivery method could potentially enhance effectiveness and reduce systemic side effects, making it a promising addition to current brain cancer therapies.

What evidence suggests that this trial's treatments could be effective for recurrent glioblastoma?

Research shows that the Cerebraca Wafer, which participants in this trial may receive, may help treat recurring glioblastoma, an aggressive brain cancer. In earlier studies, patients who received the highest dose of the Cerebraca Wafer lived for more than two years on average. One patient even lived a normal life well beyond this time. Reports indicate that the Cerebraca Wafer works better than the Gliadel wafer, another treatment for serious brain tumors. While more information is needed, these findings suggest that the Cerebraca Wafer could lead to better outcomes for people with this challenging condition. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with recurrent glioblastoma, a type of brain cancer. Participants should be eligible for surgery and have not had success with previous treatments. Specific eligibility details are not provided but typically include factors like age, health status, and prior therapy history.

Inclusion Criteria

I have a tumor visible on MRI that is at least 1 cm big.

My neurosurgeon believes my brain tumor can be completely removed.

I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

My MRI shows a large or spread-out brain tumor not suitable for surgery or specific treatment, and it's getting worse despite previous therapy.

I have had another type of cancer in the last 5 years.

I do not have any active infections or conditions that could affect my safety in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Patients undergo surgical tumor resection. In the experimental group, Cerebraca Wafer is implanted during surgery, followed by standard-of-care temozolomide therapy.

6-12 weeks

Follow-up

Participants are monitored for progression-free survival (PFS) and overall survival (OS) at 6, 9, 12, 18, and 24 months post resection.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Cerebraca Wafer
• Temozolomide

Trial Overview

The study compares the effectiveness of adding Cerebraca Wafer to standard treatment with Temozolomide alone in patients undergoing surgery for recurrent glioblastoma. It's a multi-center trial where participants are randomly assigned to one of the two treatment groups.

How Is the Trial Designed?

Group I: Treatment Group (Cerebraca Wafer) Experimental Treatment 2 Interventions

Patients will receive surgical tumor resection, implantation of 6 Cerebraca Wafer (75 mg each, total dose of 450 mg (Z)-BP) at the time of surgery, followed by SOC TMZ therapy.

Group II: Comparative Group (Standard-of-Care) Active Control 1 Intervention

Patients will receive surgical tumor resection, followed by SOC TMZ therapy.

Who Is Running the Clinical Trial?

Everfront Biotech Co., Ltd.

Lead Sponsor

Trials

3

Recruited

110+

Citations

1.

efbiotech.com

efbiotech.com/wordpress/?page_id=1778

Cerebraca® Wafer​ | Brain Tumor Treatment

Phase I clinical trial results shows median overall survival of patients who received the highest dose exceeded 2 years, and one patient still lives a normal ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8870243/

Interstitial Control-Released Polymer Carrying a Targeting ...

We showed that Cerebraca wafer has superior therapeutic effects to the Gliadel wafer in recurrent high-grade gliomas. Since no drug-related AEs ...

3.

researchgate.net

researchgate.net/figure/The-clinical-outcomes-on-Cerebraca-wafer-implantation-Representative-magnetic-resonance_fig2_358767229

The clinical outcomes on Cerebraca wafer implantation. ...

In recurrent glioblastoma, Gliadel wafer implantation after surgery has been shown to result in incomplete chemical removal of residual tumor and development ...

4.

ctv.veeva.com

ctv.veeva.com/study/comparison-of-cerebraca-wafer-plus-temozolomide-versus-temozolomide-alone-in-recurrent-glioblastoma

Comparison of Cerebraca Wafer Plus Temozolomide Versus ...

This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with ...

5.

efbiotech.com

efbiotech.com/wordpress/?page_id=6633

New Targeted Drug Cerebraca® Wafer - Everfront Biotech

Results from the published Phase I trial indicate a median overall survival period of 26.2 months for patients with recurrent malignant brain ...

6.

efbiotech.com

efbiotech.com/wordpress/?page_id=2565

Safety Evaluation for the Treatment of Glioblastoma ...

Patients who received the highest dose of 6 Cerebraca® Wafer had a survival period of more than 19 months, which was 2-3 times longer than other conventional ...

7.

ctv.veeva.com

ctv.veeva.com/study/a-phase-i-iia-study-of-cerebraca-wafer-plus-adjuvant-temozolomide-tmz-in-patients-with-recurrent-h

A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant ...

The average survival of recurrent GBM patients is 6 to 9 months regardless of the use of current available therapies.