Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors
This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.
• Age: Subjects must be 18 years of age or older.
• Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.
• Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.
• Performance Status: Subjects must have an ECOG performance status of 0-2.
• Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.
• Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.
• Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.
• Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.
• Able to receive systemic standard of care cancer therapy.
⁃ Additional criteria specifically for the glioma population:
• Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.
• Treatment: Subjects must be able to receive radiation therapy and/or chemotherapy as a part of their treatment.