A Pilot and Feasibility Study of a Dietary Intervention with Low-protein Meals in Cancer Patients Receiving Immunotherapies

Eligibility Criteria

• * Histologically documented solid tumor malignancies which is amenable for immunotherapy treatment with immune checkpoint inhibitors (i.e. PD1, PD-L1, CTLA inhibitors) as single agents or in combination.
• * Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan of the chest, abdomen, and pelvis
• * Life expectancy of at least 6 months
• * Adults ≥ 18 years of age
• * Adequate hematologic, renal, and liver function as evidenced by the following:
• * White blood cell (WBC) ≥ 2,500 cells/μL
• * Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
• * Platelet Count ≥ 100,000 cells/μL
• * Hemoglobin (HgB) ≥ 9.0 g/dL
• * Creatinine ≤ 2.0 mg/dL
• * Total bilirubin ≤ 2 x upper limit of normal (ULN)
• * Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
• * Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN
• * • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
• * Treatment with any of the following medications or interventions within 28 days of registration:
• * Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
• * High dose calcitriol \[1,25(OH)2VitD\] (i.e., \> 7.0 μg/week)
• * A requirement for systemic immunosuppressive therapy for any reason
• * Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5°F or 38.1°C) within 1 week prior to registration
• * A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
• * Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives