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

A regiszter feltételei, szó szerint

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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.

A vizsgálat 2 csoportja

• Arm A (IV L-arginine, WBRT)A vizsgált kezelés

  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 CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.

  Kezelés: Arginine, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Spectroscopy és Whole-Brain Radiotherapy

• Arm B (oral L-arginine, WBRT)A vizsgált kezelés

  Patients receive L-arginine 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.

  Kezelés: Arginine, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Spectroscopy és Whole-Brain Radiotherapy