What side effects are associated with this type of intervention?

Common treatments for malignant glioma, such as radiation therapy and temozolomide, have known side effects. Radiation therapy can cause fatigue, hair loss, skin changes, and cognitive decline. Temozolomide may lead to nausea, vomiting, fatigue, and myelosuppression. Temporally-Modulated Pulsed Radiation Therapy (TMPRT) aims to reduce these toxicities by delivering multiple small doses at specific intervals, potentially improving patient quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for malignant glioma, including radiation therapy and chemotherapeutic agents. Standard radiation therapy, often combined with the chemotherapeutic agent temozolomide, is a common approach. Temozolomide is an oral alkylating agent that has shown efficacy in improving survival rates when used concurrently with radiation therapy. While specific FDA approvals for Temporally-Modulated Pulsed Radiation Therapy (TMPRT) are not mentioned, the concept of fractionated radiation therapy, which involves delivering radiation in smaller, more frequent doses, is a well-established practice aimed at reducing toxicity and improving patient outcomes.

What other types of research exist?

Promising novel alternatives to TMPRT for malignant glioma patients include: 1) Hypofractionated Radiotherapy with concurrent and adjuvant Temozolomide (TMZ), which has shown efficacy in elderly patients with glioblastoma-multiforme. 2) Stereotactic Radiosurgery (SRS), which is effective for patients with a limited number of brain metastases and offers precise targeting to minimize damage to surrounding tissues. 3) Immunotherapy combined with radiation, such as checkpoint inhibitors with SRS, which has shown potential in improving outcomes for brain metastases from various cancers. These alternatives aim to improve efficacy while reducing toxicity, similar to the goals of TMPRT.

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Radiation Therapy

Pulsed Radiotherapy for Brain Cancer

N/A

Recruiting

Led By Jiayi Huang, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

Karnofsky performance status (KPS) of at least 70%.

Must not have

Leptomeningeal or metastatic involvement.

Prior history of grade 3 or higher radiation necrosis that is at least possibly related to prior radiotherapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at approximately 3 months, 6 months, and 12 months after start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the side effects of a new method of giving radiation in small, timed doses, in patients with certain types of brain tumors who have had earlier treatments. This approach may be more effective and less harmful.

Who is the study for?

This trial is for adults with IDH-mutant gliomas (brain tumors) who've had prior radiation. They should have a life expectancy of over a year, be able to consent, and women must use birth control. It's not for pregnant individuals or those with certain medical conditions that conflict with the treatment.

What is being tested?

The study tests TMPRT, a type of radiotherapy given in small doses at set intervals to potentially increase effectiveness and reduce side effects compared to one large dose. The focus is on patients who've previously received brain radiation therapy.

What are the potential side effects?

While specific side effects are not listed, TMPRT aims to minimize toxicity compared to traditional radiation therapy. Potential general side effects may include skin irritation, fatigue, headaches, nausea, and neurological symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using or willing to use birth control during the study.

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to the lining of my brain or other parts of my body.

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I have had severe tissue damage from radiation therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment through 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment through 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment through 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative incidence of grade 3 or higher reirradiation-related central nervous system adverse events

Frequency of acute intolerable toxicities

Secondary study objectives

Change in interference as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

Change in quality of life (QOL) as measured by self-reported QOL on the Linear Analog Scale Assessment (LASA)

Change in symptom burden as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

+2 more

Other study objectives

Relative changes of different subtypes of circulating T-cells

Relative changes of different subtypes of myeloid cells

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)Experimental Treatment1 Intervention

Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for malignant glioma include radiation therapy and chemotherapy with temozolomide. Radiation therapy works by damaging the DNA of cancer cells, leading to cell death, and is typically delivered in a targeted manner to minimize damage to surrounding healthy tissue. Temozolomide is an oral chemotherapy drug that crosses the blood-brain barrier and works by methylating DNA, which interferes with the cancer cell's ability to replicate. Temporally-modulated pulsed radiation therapy (TMPRT) is a novel approach that delivers radiation in multiple small doses at specific intervals, potentially improving efficacy and reducing toxicity. This matters for malignant glioma patients as it may enhance treatment outcomes and quality of life by minimizing side effects and maximizing the destruction of cancer cells.