Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia

2018-0073

Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone marrow failure, variable congenital abnormalities and a predisposition to malignancy, particularly acute myeloid leukemia (AML) and squamous cell carcinoma (SCC). Improved transplant outcomes are modifying the natural history of Fanconi Anemia. Improved transplant survival, no radiation exposure, and almost no GVHD increases the importance of addressing later SCC even further. The investigators hypothesize that quercetin will prevent or delay the development of SCC and associated complications, there by ameliorating or delaying the need for potentially lethal treatment with chemotherapy and/or radiation therapy for the same. Funding Source - FDA Office of Orphan Products Development (OOPD)

2018-05-08

2025-10-01

2026-10-01

Active (not recruiting)

Early phase I

48

Inclusion Criteria: * Diagnosis of FA * Able to take enteral medication * Patients ≥2 years Exclusion Criteria: * Renal failure requiring dialysis * Total bilirubin \>3 mg/dl and/or SGPT \>200 at time of enrollment * Patients receiving digoxin therapy, who are unable to discontinue either treatment due to medical reasons * Patients who are pregnant or breastfeeding or are at risk of pregnancy or fathering a baby and are unable to use acceptable methods of birth control during the length of the study * Patients who have received quercetin supplementation or other antioxidants within the last 30 days * Patients receiving radiation therapy, chemotherapy or immunotherapy for treatment of SCC.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

2023-11-01