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.
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
• Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
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
Parallel
Diet
Other interventionControl diet consisting of 20% protein, intervention diet consisting of 10% protein
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
Change in blood urea nitrogen (BUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
Change in urine urea nitrogen (UUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Includes isolation and characterization of antigen specific T cell clones
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Includes evaluation of antigen specific T cell populations by spectratyping T cell receptor expression
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Includes characterization of antigen response by cytokine and chemokine production
To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
Enrollment rate
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