Personalized Radiation Therapy for Glioblastoma

Overseen By Michelle Alonso-Basanta, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Gliadel wafers, Other malignancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

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, personalized radiation therapy for glioblastoma, a type of brain cancer. The goal is to determine if adjusting radiation doses for each individual can better control the cancer and improve survival times. Researchers also monitor side effects and the frequency of cancer recurrence. Suitable participants have undergone surgery for glioblastoma and are already receiving chemotherapy and radiation as part of their treatment. As an unphased trial, this study provides a unique opportunity to contribute to innovative cancer treatment research.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that personalized radiation therapy is safe for glioblastoma patients?

Research shows that patients with glioblastoma, a type of brain cancer, usually tolerate radiation therapy well. Radiation therapy is already a common treatment for this condition. Studies have found that improvements in radiation methods have made it more effective and safer.

Specific information about side effects for personalized radiation therapy is not available. However, since radiation therapy is widely used, doctors generally know and manage any possible side effects. These side effects might include tiredness, changes to the skin, or hair loss in the treated area, but they can differ from person to person.

Although this trial is a pilot study and lacks detailed safety data, extensive previous research supports the use of radiation therapy for glioblastoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Personalized Radiation Therapy for glioblastoma is unique because it customizes the radiation dose specifically for each patient's tumor characteristics. Unlike standard radiation therapies, which often use a one-size-fits-all approach, this treatment aims to maximize the effectiveness of radiation by tailoring it to the individual, potentially improving outcomes and reducing side effects. Researchers are excited about this approach because it represents a new frontier in precision medicine, offering hope for better-targeted therapies in the fight against this aggressive brain cancer.

What evidence suggests that personalized radiation therapy might be an effective treatment for glioblastoma?

Research has shown that personalized radiation therapy, which participants in this trial will receive, might help patients with glioblastoma, a type of brain cancer, live longer. Studies have found that this method can double survival times compared to standard treatments. Personalized radiation targets tumors more accurately, potentially improving cancer control and reducing side effects. Reviews of past clinical experiences suggest that these advanced methods can enhance the balance between treatment effectiveness and patient safety. This makes personalized radiation a promising option for treating glioblastoma. ^{1 2 6 7 8}

Who Is on the Research Team?

Michelle Alonso-Basanta

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of WHO Grade IV glioblastoma who have had most of their tumor surgically removed and are set to receive chemoradiation. Participants must be able to consent and have a Karnofsky Performance Status (KPS) score of at least 70, indicating they can care for themselves.

Inclusion Criteria

Ability to give signed informed consent

I am able to care for myself but may not be able to do active work.

I have a high-grade brain tumor and am receiving chemotherapy and radiation after surgery.

Exclusion Criteria

I am currently being treated for another cancer.

Participation in another investigational trial

I have had Gliadel wafers placed in my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive personalized dose-escalated radiation therapy

6-8 weeks

Follow-up

Participants are monitored for safety, toxicity, patterns of recurrence, and overall survival

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Radiation Therapy

Trial Overview

The study tests personalized dose-escalation radiation therapy in glioblastoma patients. It aims to see how well it works by looking at the time before the cancer worsens, side effects, where and when the cancer might come back, and overall survival rates.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Dose-escalated radiation therapy

Personalized Radiation Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Personalized Radiation Therapy for:

• HPV-positive throat cancer

Approved in European Union as De-escalated Radiation Therapy for:

• HPV-positive oropharyngeal squamous cell carcinoma

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

Recent advances in radiation therapy for malignant glioma, such as stereotactic radiotherapy and charged particle therapy, aim to improve treatment efficacy while reducing damage to healthy tissues.

Combining these advanced radiation techniques with targeted biochemotherapies may enhance therapeutic outcomes for patients with malignant glioma, which has historically had a poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted radiotherapy for malignant gliomas. Oh, DS., Adamson, DC., Kirkpatrick, JP.[2019]

Fractionated stereotactic re-irradiation shows a 12-month overall survival rate of 33.1% and a progression-free survival rate of 13.4% in patients with recurrent glioblastoma, based on a meta-analysis of eight studies involving 307 patients.

The treatment has a low incidence of radiation necrosis, indicating it is a relatively safe option for patients, with factors like age and radiation dose affecting survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated stereotactic re-irradiation for recurrent glioblastoma: A systematic review and meta-analysis. Luo, T., Feng, J., Sun, P.[2023]

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Personalized radiation therapy for glioblastoma - Haque

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Personalized radiation therapy for glioblastoma

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sciencedirect.com/science/article/pii/S2452109425001009

Comparative Outcomes of Standard Radiation Therapy ...

We retrospectively reviewed 96 adults with newly diagnosed GBM treated at our institution between 2018 and 2024. Inclusion criteria included the age of 18 years ...

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Concurrent therapy to enhance radiotherapeutic outcomes in ...

The most effective treatment for glioblastoma is maximal safe surgical resection followed by concurrent treatment with TMZ and RT followed by adjuvant TMZ.

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Radiation therapy for glioblastoma: Executive summary of ...

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ASTRO updates guideline on radiation therapy for high-grade diffuse glioma, the most common primary brain tumor in adults. Evidence-based ...

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Safety and Preliminary Efficacy of AZD1390 + Radiation ...

This global, Phase 1, open-label study (NCT03423628) evaluates the safety and preliminary efficacy of escalating doses of AZD1390 and radiation therapy (RT) in ...

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Study Results | NCT03746080 | Whole Brain Radiation ...

Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma · Results Overview · Study ...