Gliadel Wafer (carmustine implant) / Eisai, Azurity Pharma - LARVOL DELTA

Vigilant Observation of Gliadel® Wafer Implant (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel® Wafer (Carmustine Implant) Used in Usual Medical Practice (SNO 2026) - No abstract available

Clinical

Engineering Glioma-Cell-Derived Exosomes as Trojan Horse for Precisely Targeted Chemotherapy of Glioblastoma. (PubMed, Biomater Res) - "Although the Gliadel wafer locally delivers carmustine, its clinical application is limited by suboptimal therapeutic efficacy and poor conformability to irregular resection cavities...Compared to non-exosomal controls (DMSNs@CS), Exo-DMSNs@CS markedly suppressed tumor recurrence and prolonged survival. Our findings demonstrate that this Trojan-horse-inspired delivery strategy-leveraging tumor-derived exosomes to encapsulate drug-loaded nanoparticles-enables a localized and precise tumor-targeted drug delivery system, representing a promising therapeutic paradigm for GBM treatment."

Journal • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Recurrence patterns and site-level survival in the previous phase III study of IL13-PE38QQR: Implications for drug distribution variability. (ASCO 2026) - P3 | "Clinical outcomes following IL13-PE38QQR therapy were strongly associated with delivery efficiency and treatment-team experience. Radiolabeled distribution studies, experience-dependent survival effects, and recurrence patterns in long-term survivors indicate that outcome variability was driven primarily by technical limitations in drug delivery rather than tumor biology. This study represented the first large-scale evaluation of CED in the absence of purpose-built delivery technology, relying on complex, nonstandardized surgical workflows."

P3 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • IL13

A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: University of Nebraska | Trial completion date: Dec 2028 ➔ Dec 2029 | Trial primary completion date: Dec 2027 ➔ Dec 2028

Trial completion date • Trial primary completion date • Brain Cancer • CNS Disorders • Oncology • Solid Tumor

Limitations of Gliadel Wafers and Strategies for Next-Generation Local Delivery Systems for Glioblastoma. (PubMed, Cancers (Basel)) - "The only U.S. Food and Drug Administration (FDA)-approved implantable intracranial chemotherapy is the carmustine (1,3-bis[2-chloroethyl]-1-nitrosourea; BCNU)-impregnated polyanhydride wafer (Gliadel wafer), indicated for newly diagnosed high-grade glioma and recurrent GBM... Next-generation local drug-delivery systems should include multiple synergistic tumor-selective drugs that can be released in a controlled, sustained manner deep into the residual tumor. Preclinical testing of these systems should be conducted in clinically relevant animal models that are more translatable than those used in early Gliadel wafer studies."

Journal • Review • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Gliadel for brain metastasis: Results from the VIGILANT prospective registry (SNO 2025) - "GLIADEL implant, a biodegradable carmustine chemotherapy wafer that delivers high dose carmustine within a tumor, shows efficacy in malignant glioma treatment, while limited data exists in brain metastasis...43 total patients had adverse events; two considered possibly GLIADEL related. Conclusions Placing GLIADEL wafers for treatment of brain metastases may favorably increase OS (14.9 months vs. 7.9-24 months) and decrease 1 year local progression rates (12% vs up to 39%) compared to the literature and was well tolerated in this population, the majority whom failed initial radiosurgical management."

Clinical • Brain Cancer • Glioma • High Grade Glioma • Solid Tumor

Single institution retrospective analysis of survival of patients with MGMT unmethylated glioblastoma (IDH-wt) at a comprehensive neuro-oncology center (SNO 2025) - "The median survival of patients with MGMT unmethylated glioblastomas at multidisciplinary neuro-oncology centers exceeds national expectations, despite receiving the same standard of care treatment. The survival benefit is likely due to multiple factors, including access to advanced neurosurgical care, multidisciplinary tumor board discussions guiding meticulous treatment plans, judicious use of steroids, and better management of neurologic comorbidities."

Retrospective data • Brain Cancer • Glioblastoma • Solid Tumor • MGMT • NF1 • RB1

Gliadel for brain metastasis: Results from the VIGILANT prospective registry (WFNOS 2025) - "GLIADEL implant, a biodegradable carmustine chemotherapy wafer that delivers high dose carmustine within a tumor, shows efficacy in malignant glioma treatment, while limited data exists in brain metastasis...43 total patients had adverse events; two considered possibly GLIADEL related. Conclusions Placing GLIADEL wafers for treatment of brain metastases may favorably increase OS (14.9 months vs. 7.9-24 months) and decrease 1 year local progression rates (12% vs up to 39%) compared to the literature and was well tolerated in this population, the majority whom failed initial radiosurgical management."

Clinical • Brain Cancer • Glioma • High Grade Glioma • Solid Tumor

Single institution retrospective analysis of survival of patients with MGMT unmethylated glioblastoma (IDH-wt) at a comprehensive neuro-oncology center (WFNOS 2025) - "The median survival of patients with MGMT unmethylated glioblastomas at multidisciplinary neuro-oncology centers exceeds national expectations, despite receiving the same standard of care treatment. The survival benefit is likely due to multiple factors, including access to advanced neurosurgical care, multidisciplinary tumor board discussions guiding meticulous treatment plans, judicious use of steroids, and better management of neurologic comorbidities."

Retrospective data • Brain Cancer • Glioblastoma • Solid Tumor • MGMT • NF1 • RB1

Gliadel use in a pregnant patient with malignant glioma: a case report. (PubMed, Front Oncol) - "Pharmacokinetics suggests minimal systemic absorption, limiting fetal exposure. Our case adds to the limited literature, highlighting the feasibility of local chemotherapy with carmustine wafers during the second trimester."

Journal • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (clinicaltrials.gov) - P=N/A | N=272 | Completed | Sponsor: Arbor Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2025 ➔ Jun 2025 | Trial primary completion date: Oct 2025 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor

A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: University of Nebraska | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Brain Cancer • CNS Disorders • Oncology • Solid Tumor

Developing a novel injectable immunotherapeutic gel for encapsulation of natural killer cells for post-surgical glioblastoma treatment (SNO 2024) - "To date, temozolomide (TMZ) and the Gliadel wafer have been clinically used as standard chemotherapy agents after brain tumor resection...In a brain tumor animal model, the use of hydrogel-NK cells significantly inhibited tumor proliferation and prolonged animal survival time. In conclusion, this therapeutic hydrogel carrying NK cells can serve as a novel post-operation adjuvant therapeutic tool for malignant brain tumors."

Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Unmanageable Cerebrospinal Fluid Leakage With Eosinophilic Meningitis in a Gliadel Wafer Implant Patient. (PubMed, Cureus) - "DLST against Gliadel wafers is also useful for diagnosis when it is available. To control the hydrocephalus, not only the shunt procedure but also wafer removal must be considered; however, patients with limited life expectancy are generally hesitant to undergo such additional procedures."

Journal • Allergy • Brain Cancer • CNS Disorders • CNS Tumor • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Ventriculomegaly

Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM (clinicaltrials.gov) - P1/2 | N=8 | Terminated | Sponsor: St. Joseph's Hospital and Medical Center, Phoenix | N=80 ➔ 8 | Unknown status ➔ Terminated; met stopping rules for futility

Enrollment change • Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (clinicaltrials.gov) - P=N/A | N=272 | Active, not recruiting | Sponsor: Arbor Pharmaceuticals, Inc. | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Oncology

Brain Tumor-Related Pain: Innovative Approaches to Diagnosis, Treatment, and Quality of Life Issues: A Systematic Review and Meta-analysis (SNO 2022) - "Timely diagnosis of the gliomas has significant improvements to the overall survival. Treatment approaches explored in the studies include Temozolomide (TZ), Gliadel Wafer, immunogeno-type, peptide vaccination, Bevacizumab, chemotherapy, radiation therapy, and Temsirolimus. Chemotherapy and radiation therapy have been linked to a deteriorated quality of life of the patients"

HEOR • Retrospective data • Review • Brain Cancer • Fatigue • Glioblastoma • Glioma • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (clinicaltrials.gov) - P=N/A | N=271 | Active, not recruiting | Sponsor: Arbor Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | N=500 ➔ 271

Enrollment change • Enrollment closed • Brain Cancer • CNS Tumor • Oncology

Interstitial Control-Released Polymer Carrying a Targeting Small-Molecule Drug Reduces PD-L1 and MGMT Expression in Recurrent High-Grade Gliomas with TMZ Resistance. (PubMed, Cancers (Basel)) - "Furthermore, temozolomide (TMZ) resistance caused by O-methylguanine-DNA-methyltransferase (MGMT) activation and programmed cell death-ligand 1 (PD-L1) expression leads to immune-cold lesions that result in poorer prognosis...Furthermore, BP inhibited PD-L1 expression, thereby activating T-cell cytotoxicity and increasing interferon-gamma (IFN-γ) secretion. The better therapeutic effect of Cerebraca wafer on recurrent high-grade glioma could occur through re-sensitization of TMZ and reduction of PD-L1."

IO biomarker • Journal • Brain Cancer • CNS Disorders • Glioblastoma • Glioma • Oncology • Solid Tumor • IFNG • MGMT

Long-term effectiveness of Gliadel implant for malignant glioma and prognostic factors for survival: 3-year results of a postmarketing surveillance in Japan. (PubMed, Neurooncol Adv) - P=N/A | "Up to 8 Gliadel wafers (61.6 mg of carmustine) were placed over the tumor resection site...With a careful interpretation of indirect comparisons with previously reported data, the results suggest that prognosis could be improved with Gliadel implants. NCT02300506."

Biomarker • Journal • P4 data • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Early Therapeutic Interventions for Newly Diagnosed Glioblastoma: Rationale and Review of the Literature. (PubMed, Curr Oncol Rep) - "Finally, we discuss the most promising strategies that could benefit future glioblastoma patients. There is biological rationale to suggest that early interventions could improve the outcome of glioblastoma patients and they should be investigated in future trials."

Journal • Review • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Local Delivery and Glioblastoma: Why Not Combining Sustained Release and Targeting? (PubMed, Front Med Technol) - "The standard of care used in clinic is the Stupp's protocol which consists of a maximal resection of the tumor when possible, followed by radio and chemotherapy using temozolomide...The purpose of this review is to provide an overview of recent advances in the development of innovative therapeutic strategies for glioblastoma using an implant-type approach. The combination of this local strategy with effective targeting of the tumor microenvironment as a whole, also developed in this review, may be of interest to alleviate some of the obstacles encountered in the treatment of glioblastoma."

Journal • Review • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

A numerical study of the distribution of chemotherapeutic drug carmustine in brain glioblastoma. (PubMed, Drug Deliv Transl Res) - "To cure the illness in the brain glioblastoma, the Gliadel wafer, as the first FDA-approved chemotherapy, was available on the market since 1997. Moreover, the simulation approach can be used as the guild for remedy optimization and dynamic analysis of other drugs (paclitaxel) for tumor treatment in the clinic. This mathematical model has wide applications about drug release in multiple dosage forms, such as long sustained release microspheres, oral extended release hydrophilic matrix tablets, hydrogel, and sustained release topical rings."

Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

[VIRTUAL] The impact of carmustine implants and concurrent chemo-radiation on outcomes in primary treatment of glioblastoma: A single centre experience over a 10-year period (ESMO 2021) - "Within our select cohort of glioblastoma patients, carmustine wafer insertion at the time of primary de-bulking surgery showed improved overall survival without impacting the progression free survival."

Clinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Current Perspective on the Natural Compounds and Drug Delivery Techniques in Glioblastoma Multiforme. (PubMed, Cancers (Basel)) - "The current standard pharmacological regimen available for glioblastomas, such as radiotherapy and surgical resection following treatment with chemotherapeutic drug temozolomide, remains fatal, due to drug resistance, metastasis and tumor recurrence...Consequently, our review emphasizes several natural compounds in GBM treatment. We also assessed the potential of drug delivery techniques such as nanoparticles, Gliadel wafers and drug delivery using cellular carriers which could lead to a novel path for the obliteration of GBM."

Journal • Review • Brain Cancer • Glioblastoma • Immunology • Inflammation • Oncology • Solid Tumor