CLINICAL TRIALS PROFILE FOR GLIADEL

All Clinical Trials for GLIADEL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003463 ↗	Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas	Completed	National Cancer Institute (NCI)	Phase 1	1998-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.
NCT00003463 ↗	Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas	Completed	Duke University	Phase 1	1998-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.
NCT00003467 ↗	Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma	Completed	National Cancer Institute (NCI)	Phase 2	1998-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.
NCT00003467 ↗	Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma	Completed	Duke University	Phase 2	1998-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.
NCT00003876 ↗	Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma	Completed	Barrett Cancer Center	Phase 1	1999-04-01	RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor cells following surgery. PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma.
NCT00003878 ↗	Carmustine Implants in Treating Patients With Brain Metastases	Completed	National Cancer Institute (NCI)	Phase 2	2002-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.
NCT00003878 ↗	Carmustine Implants in Treating Patients With Brain Metastases	Completed	New Approaches to Brain Tumor Therapy Consortium	Phase 2	2002-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.

Clinical Trial Conditions for GLIADEL

Condition Name

Condition Name for GLIADEL
Intervention	Trials
Glioblastoma Multiforme	8
Brain and Central Nervous System Tumors	8
Glioblastoma	5
Recurrent Diffuse Large B-Cell Lymphoma	3

Condition MeSH

Condition MeSH for GLIADEL
Intervention	Trials
Glioblastoma	17
Glioma	16
Lymphoma	13
Lymphoma, Non-Hodgkin	11

Clinical Trial Locations for GLIADEL

Trials by Country

Trials by Country for GLIADEL
Location	Trials
United States	170
Canada	10
United Kingdom	4
Germany	3
Israel	2

Trials by US State

Trials by US State for GLIADEL
Location	Trials
North Carolina	15
Washington	12
Texas	11
Ohio	9
California	8

Clinical Trial Progress for GLIADEL

Clinical Trial Phase

Clinical Trial Phase for GLIADEL
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	21
Phase 1/Phase 2	9

Clinical Trial Status

Clinical Trial Status for GLIADEL
Clinical Trial Phase	Trials
Completed	23
Unknown status	7
Terminated	7

Clinical Trial Sponsors for GLIADEL

Sponsor Name

Sponsor Name for GLIADEL
Sponsor	Trials
National Cancer Institute (NCI)	25
Fred Hutchinson Cancer Research Center	8
Eisai Inc.	6

Sponsor Type

Sponsor Type for GLIADEL
Sponsor	Trials
Other	36
NIH	26
Industry	17

Gliadel: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Gliadel (carmustine implant) has established itself as a pivotal adjunct therapy in the management of malignant brain tumors. This biodegradable implant delivers calibrated doses of carmustine directly into the resection cavity, thus offering localized chemotherapy for glioblastoma multiforme (GBM) and recurrent high-grade gliomas. As the glioma treatment landscape evolves, understanding the latest clinical trial developments, market trajectory, and future growth potential for Gliadel is critical for stakeholders ranging from biotech firms to healthcare providers.

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Clinical Trials Update

Recent and Ongoing Studies

While Gliadel has been commercially available since 1998, recent clinical trials focus on refining its application, expanding indications, and combining it with novel therapies:

• Recurrent Glioblastoma Treatment Trials: Multiple Phase II studies evaluate combining Gliadel with systemic therapies, like temozolomide and immune checkpoint inhibitors, to enhance therapeutic efficacy. A notable trial (NCT04444645) investigates Gliadel combined with nivolumab in recurrent GBM, aiming to assess safety and survival benefits. Preliminary data suggest that combination therapy may improve progression-free survival (PFS), though definitive conclusions await mature results.

• Novel Application in Pediatric and Other Tumor Types: Current trials explore the feasibility of using Gliadel in pediatric high-grade gliomas. The challenge remains balancing efficacy with safety in this population, but early Phase I results demonstrate tolerability.

• Formulation Improvements: Researchers investigate biodegradable polymers that optimize drug release profiles, potentially extending Gliadel’s shelf life and reducing adverse events. Innovations aim to mitigate postoperative complications like cerebral edema and infection.

Regulatory Milestones

Despite its longevity, Gliadel’s approval boundaries are under review:

• FDA Status: Gliadel remains FDA-approved for postoperative treatment of recurrent high-grade gliomas, with supplemental approvals expanding its use in newly diagnosed cases elsewhere. The evolving regulatory landscape reflects ongoing evaluation of combination strategies and new formulations.

• EU and Other Markets: The European Medicines Agency (EMA) has approved Gliadel with similar indications, although national approvals vary. Ongoing submissions seek broader indications for newly diagnosed GBM.

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Market Analysis

Global Market Size and Growth Drivers

The glioma therapeutics market is projected to reach approximately USD 2.5 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of around 8-10%[1]. Gliadel contributes notably to this market through its unique localized delivery approach.

Key growth drivers include:

• Rising Incidence of Gliomas: Annually, over 240,000 primary brain tumors are diagnosed globally, with gliomas constituting roughly 80% of malignant cases[2]. The increasing prevalence underscores demand for effective localized therapies like Gliadel.

• Limitations of Systemic Chemotherapy: Blood-brain barrier (BBB) limitations restrict systemic drug efficacy, making intracranial implants a preferred approach. Gliadel’s direct delivery circumvents BBB issues, reinforcing its clinical value.

• Advancements in Surgical Techniques: Increased neurosurgical interventions, including minimally invasive techniques, lead to higher eligible patient pools for Gliadel implantation.

• Expanding Indications: Trials exploring Gliadel in combination therapies and in patients with recurrent tumors open new revenue streams.

Competitive Landscape

Gliadel operates in a niche segment, competing primarily with:

• Systemic Chemotherapies: Temozolomide remains first-line but is limited by systemic toxicity and resistance.

• Tumor Treating Fields (TTFields): Devices like NovoCure’s Optune have gained FDA approval for GBM, providing an alternative therapy. However, the invasive nature of Gliadel and the need for surgical placement distinguish its market position.

• Emerging Localized Therapies: Liposomal formulations and gene therapies are under investigation, potentially challenging Gliadel’s dominance.

Market Challenges

• Surgical Dependence: The requirement for surgical implantation limits applicability to patients eligible for surgical resection.

• Adverse Events: Postoperative complications, including brain edema and infection, impact adoption rates.

• Cost and Reimbursement: High costs and variable reimbursement policies across regions influence market penetration.

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Projection and Future Trends

Market Expansion Opportunities

• Combination Regimens: Clinical trials demonstrating improved survival with Gliadel combined with emerging immunotherapies can facilitate regulatory approvals for new indications, broadening the market.

• Personalized Medicine: Biomarker-driven patient selection could optimize outcomes and expand usage.

• Global Penetration: Emerging markets with rising glioma incidence and increasing healthcare infrastructure will present new growth opportunities.

Innovations and R&D Focus

• Next-generation Implants: Research into biodegradable polymers with controlled release kinetics aims to improve efficacy and safety profiles.

• Integration with Adjunctive Therapies: The synergy between Gliadel and modalities like TTFields or laser interstitial thermal therapy (LITT) could redefine treatment protocols.

Projection Summary

By 2030, the Gliadel market is anticipated to grow at a CAGR exceeding 8%, driven by technological innovations, expanded indications, and increased awareness. Strategic collaborations between pharmaceutical companies and healthcare providers will be pivotal in maximizing global reach.

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Key Takeaways

• Gliadel remains a cornerstone of localized chemotherapy for high-grade gliomas, with ongoing trials focusing on combination therapies and formulation enhancements.
• Market growth is robust, propelled by rising glioma incidence, need for effective localized treatments, and surgical advancements.
• Competitive pressures are moderate but will intensify with the advent of new local and systemic therapies.
• Future success hinges on demonstrating efficacy in broader patient populations, reducing adverse events, and improving delivery mechanisms.
• Strategic investments in R&D and global market penetration promise sustained growth over the next decade.

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FAQs

1. What are the latest clinical trial results for Gliadel?
Recent trials exploring combination therapies with immunotherapies such as nivolumab have shown promising safety profiles and hints of improved progression-free survival, but conclusive efficacy data remains pending.

2. How does Gliadel compare to systemic chemotherapy?
Gliadel offers targeted drug delivery directly into the brain, circumventing the blood-brain barrier—a major limitation of systemic chemotherapies like temozolomide. It reduces systemic toxicity and provides localized control of residual tumor cells.

3. Are there new formulations of Gliadel under development?
Yes, ongoing research aims to develop advanced biodegradable delivery systems with tailored release profiles to enhance efficacy and reduce postoperative complications.

4. What are the primary challenges facing Gliadel in market adoption?
Dependence on surgical placement, postoperative complications, costs, and competition from emerging therapies are significant hurdles.

5. What is the outlook for Gliadel in future glioma treatment?
The outlook is optimistic, with potential for expansion into newly diagnosed gliomas, combination regimens, and personalized approaches—fostering sustained growth in the global market.

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References

[1] MarketsandMarkets, “Glioma Therapeutics Market,” 2022.
[2] World Health Organization, “Global Incidence of Brain Tumors,” 2021.