This phase I study evaluates the safety and best dose of curcumin and high phenolic extra virgin olive oil for slowing or stopping the growth of tumors in patients with neurofibromatosis type 1. Curcumin is a substance found in the root of turmeric that can have effects on cells or tissues. High phenolic olive oil is a special type of olive oil high in phenolic compounds, which have anti-inflammatory properties. Inflammation is an important factor in tumor growth in neurofibromatosis type 1. The anti-inflammatory effects of curcumin and high phenolic extra virgin olive oil may be able to stop the process of tumor growth in patients with neurofibromatosis type 1.
Additional locations may be listed on ClinicalTrials.gov for NCT05363267.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. The primary objective of this study is to establish the safety and recommend a phase II dose (RP2D) of curcumin and oleocanthal-rich olive oil supplementation in adult neurofibromatosis type 1 (NF-1) persons with cutaneous neurofibromas (cNF).
SECONDARY OBJECTIVES:
I. To characterize the toxicities associated with the planned intervention.
II. To assess the effect of the intervention on quality of life focusing on skin related morbidity and pain using the Skindex.
III. To evaluate the effect of the intervention on metabolic parameters (body mass index [BMI], lipid panel).
IV. To determine preliminary efficacy of the intervention based on change in measurements of targeted existing cNFs and the development of new cNFs.
V. To identify issues with compliance to the planned intervention.
CORRELATIVE OBJECTIVES:
I. To assess the effect of the intervention on plexiform neurofibromas (pNFs) using linear and volumetric magnetic resonance imaging (MRI) measurements.
II. To evaluate impact of the intervention on serum biomarkers (TNFalpha, INF-gamma, IL-6 and IGFBP-1).
III. To study pharmacokinetics and pharmacodynamics of curcumin and oleocanthal.
OUTLINE: This is a dose escalation study of curcumin and high phenolic extra virgin olive oil.
Patients receive curcumin orally (PO) twice daily (BID) and high phenolic extra virgin olive oil PO BID for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the study. Patients with pNFs also undergo MRI scans throughout the study.
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorChristopher Loren Moertel
