Summary
The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.
Detailed Description
This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (\~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion 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
Exclusion Criteria:
* • 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