Radiation Therapy for Recurrent Brain Tumors

Recruiting in Palo Alto (17 mi)

Overseen by Peter GK Mathen, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: National Cancer Institute (NCI)

Must not be taking: Bevacizumab, Temozolomide, Cytotoxic chemotherapy, others

Disqualifiers: Pregnancy, Radiation sensitivity, Uncontrolled illness, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy. Objective: To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment. Eligibility: People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment. Design: Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected. Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments. Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit. Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends. Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot have had certain treatments like Bevacizumab, Temozolomide, or cytotoxic chemotherapy within 2-3 weeks before starting the study. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Hypofractionation Trial of Re-irradiation for recurrent brain tumors?

Research shows that hypofractionated stereotactic radiotherapy (HFSRT) and fractionated stereotactic radiotherapy (FSRT) are effective in treating recurrent malignant gliomas and brain metastases, providing a viable option for patients who have previously undergone radiation. These treatments help manage tumor growth and can reduce the need for additional surgeries.

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Is radiation therapy for recurrent brain tumors safe?

Research shows that hypofractionated stereotactic radiotherapy (HFSRT) and hypofractionated radiosurgery (hfSRS) are generally safe for treating brain tumors, with side effects similar to those of single-fraction treatments. These methods have been used for various brain conditions, and studies suggest they have manageable toxicity levels.

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How is the treatment Hypofractionation Trial of Re-irradiation different from other treatments for recurrent brain tumors?

This treatment uses hypofractionated stereotactic radiotherapy (HFSRT), which delivers radiation in larger doses over fewer sessions, making it a quicker option compared to traditional methods. It is designed to minimize the need for reoperation by reducing toxicity, unlike single-fraction stereotactic radiosurgery (SRS) and brachytherapy.

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Eligibility Criteria

This trial is for adults over 18 with a type of brain cancer called grade 4 glioblastoma, which has returned after initial radiation therapy. Participants must have completed their first round of treatment and be in good enough health to undergo further radiation.

Inclusion Criteria

- Absolute neutrophil count (ANC) greater than or equal to 1,000/microL

I am mostly able to care for myself.

My organs and bone marrow work well.

Exclusion Criteria

I have not started the study therapy yet.

I may have a condition that makes me sensitive to radiation.

I cannot have an MRI or gadolinium contrast for any reason.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Re-irradiation Treatment

Participants undergo re-irradiation treatment 4 times per week for 1, 2, or 3 weeks, depending on the assigned dose level.

1-3 weeks

4 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits 1 month after treatment, then every 2 months for 6 months, and every 3 months up to 3 years. Remote follow-up continues for an additional 2 years.

5 years

In-person visits and remote follow-ups

Participant Groups

The study is testing different schedules of re-irradiation (radiation therapy) on patients whose glioblastoma has recurred. The goal is to find the safest way to administer this treatment by varying the frequency and duration over one, two, or three weeks.

Group I: 2/Arm 2 Experimental Treatment 1 Intervention

MTD of re-irradiation dose.

Group II: 1/Arm 1 Experimental Treatment 1 Intervention

Fraction size escalation of 3 planned re-irradiation dose levels.

Hypofractionation Trial of Re-irradiation is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Re-irradiation for:

• Recurrent glioblastoma multiforme (GBM)

🇺🇸 Approved in United States as Re-irradiation for:

• Recurrent glioblastoma multiforme (GBM)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Institutes of Health Clinical Center Bethesda, MD

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic re-irradiation: treatment option in recurrent malignant glioma. [2022] Hypofractionated stereotactic radiotherapy (HFSRT) is one salvage treatment option in previously irradiated patients with recurrent malignant glioma. We analyzed the results of HFSRT and prognostic factors in a single-institution series.

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

Stereotactic radiosurgery and stereotactic radiotherapy for brain metastases. [2022] Stereotactic radiosurgery (SRS) and hypofractionated stereotactic radiotherapy (HFSRT) have become important treatment modalities for brain metastases. While effective, there are still areas of extensive debate on its appropriate use in patients with life-limiting diseases. This review provides an overview of the indications and challenges of SRS and HFSRT in the management of brain metastases.

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

A phase I dose escalation study of hypofractionated stereotactic radiotherapy as salvage therapy for persistent or recurrent malignant glioma. [2022] A phase I dose escalation of hypofractionated stereotactic radiotherapy (H-SRT) in recurrent or persistent malignant gliomas as a means of increasing the biologically effective dose and decreasing the high rate of reoperation due to toxicity associated with single-fraction stereotactic radiosurgery (SRS) and brachytherapy.

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

Efficacy of fractionated stereotactic reirradiation in recurrent gliomas: long-term results in 172 patients treated in a single institution. [2022] To evaluate the efficacy of fractionated stereotactic radiotherapy (FSRT) performed as reirradiation in 172 patients with recurrent low- and high-grade gliomas.

5. Ireland pubmed.ncbi.nlm.nih.gov

Phase II trial of hypofractionated stereotactic radiotherapy for brain metastases: results and toxicity. [2022] To prospectively evaluate efficacy and side effects of hypofractionated stereotactic radiotherapy (hfSRT) for irresectable brain metastases not amenable to radiosurgery (SRS).

6. England pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic radiotherapy of limited brain metastases: a single-centre individualized treatment approach. [2022] We retrospectively report treatment results of our single-centre experience with hypofractionated stereotactic radiotherapy (hfSRT) of limited brain metastases in primary and recurrence disease situations. Our aim was to find the most effective and safe dose concept.

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

The use of Hypofractionated Radiosurgery for the Treatment of Intracranial Lesions Unsuitable for Single-Fraction Radiosurgery. [2019] Stereotactic radiosurgery (SRS) is commonly used in the treatment of brain metastases, benign tumors, and arteriovenous malformations (AVM). Single-fraction radiosurgery, though ubiquitous, is limited by lesion size and location. In these cases, hypofractionated radiosurgery (hfSRS) offers comparable efficacy and toxicity. We review the recent literature concerning hfSRS in the treatment of brain metastases, benign tumors, and AVMs that are poorly suited for single-fraction SRS. Published retrospective analyses suggest that local control rates for brain metastases and benign tumors, as well as the rates of AVM obliteration, following hfSRS treatment are comparable to those reported for single-fraction SRS. Additionally, the toxicities from hypofractionated treatment appear comparable to those seen with single-fractioned SRS to small lesions.