Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases

Официальное название

Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases

Обзор

This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy.

Подробное описание

PRIMARY OBJECTIVE:

I. Determine the bioavailability of orally-administered arginine (L-arginine).

SECONDARY OBJECTIVES:

I. Test the safety of daily arginine administration with standard-fractionation whole brain radiation therapy (WBRT).

II. Determine the side effect profile of oral and intravenous (IV) L-arginine. III. Quantify frontal cortex blood volume/flow changes following L-arginine (L-arg) administration.

IV. Describe immunological effects of oral versus (vs.) IV arginine. V. Describe the metabolic effects of oral vs. IV arginine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive L-arginine IV over 10-20 minutes followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) at screening, undergo collection of blood samples and spectroscopy on study, and undergo magnetic resonance imaging (MRI) at screening and follow up.

ARM B: Patients receive L-arginine orally (PO) followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.

After completion of study treatment, patients are followed up at 1 month and then quarterly for 1 year.

Вмешательства

• Пищевая добавка Arginine
  Given IV or PO
• Процедура Biospecimen Collection
  Undergo collection of blood samples
• Процедура Computed Tomography
  Undergo CT
• Процедура Magnetic Resonance Imaging
  Undergo MRI
• Процедура Spectroscopy
  Undergo spectroscopy
• Лучевая терапия Whole-Brain Radiotherapy
  Undergo WBRT

Первичные конечные точки

• Peak plasma L-arginine (arginine) and arginine metabolite concentration [Срок оценки: Within 4 hours of oral and intravenous (IV) dosing of L-arginine]

Вторичные конечные точки (5)

• Incidence of adverse events associated with delivering L-arginine with standard fractionation whole brain radiation therapy [Срок оценки: At 1 week into radiation and at completion of 2 week course]
• Side effect profile of oral and IV arginine [Срок оценки: On days 1, 5, and 10]
• Frontal cortex blood volume/flow changes with L-arginine administration [Срок оценки: Up to 1 year]
• Describe The Immunological Effects of Oral versus IV Arginine [Срок оценки: Up to 10 days]
• Describe The Metabolic Effects of Oral versus IV Arginine [Срок оценки: Up to 10 days]

Критерии участия

Критерии включения

• Diagnosis of brain metastases from any primary cancer
• Planned to undergo whole-brain radiation therapy (Hippocampal avoidant is ok)
• No systemic anti-neoplastic agent concurrent with WBRT (memantine is ok)
• Not inpatient at the time of treatment start
• Age 18 or older
• Able to consent for self

Критерии исключения

• Patient unwilling/unable to receive daily arginine treatment (IV or oral) for the 10 days of WBRT
• Systemic therapy continuing during WBRT
• Creatinine > 1.5 x the upper limit of normal
• Alanine aminotransferase (ALT) > 6x the upper limit of normal
• Patient planned to be treated as an inpatient
• Age < 18 years
• Adult not able to consent for self
• Pregnant
• Prisoners
• Cognitively impaired/impaired decision-making capacity

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Emory University Hospital/Winship Cancer Institute — Atlanta

Идентификаторы

NCT: NCT06328686 · STUDY00005787 · NCI-2023-10895 · STUDY00005787 · WINSHIP5883-23 · P30CA138292

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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