Quercetin for Squamous Cell Cancer in Fanconi Anemia

Palo Alto (17 mi)

Overseen byParinda A Mehta, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Children's Hospital Medical Center, Cincinnati

No Placebo Group

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?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)

Eligibility Criteria

This trial is for individuals over 2 years old with Fanconi anemia (FA), who can take medication by mouth. It's not for those pregnant, breastfeeding, at risk of pregnancy without birth control, or have taken antioxidants like quercetin in the last month. People undergoing cancer treatments or with certain liver and kidney conditions, or on digoxin therapy that can't be stopped are also excluded.

Inclusion Criteria

I am 2 years old or older.

I can take medicine by mouth.

I have been diagnosed with Fanconi anemia.

Exclusion Criteria

I am on dialysis for kidney failure.

I haven't taken quercetin or other antioxidants in the last 30 days.

I am currently undergoing treatment for squamous cell carcinoma.

I am on digoxin and cannot stop it for medical reasons.

Treatment Details

The study tests if a dietary supplement called Quercetin can prevent or delay Squamous Cell Carcinoma (SCC) in patients with FA. The goal is to reduce the need for harsher treatments like chemotherapy and radiation therapy which are typically used to treat SCC.

1Treatment groups

Experimental Treatment

Group I: QuercetinExperimental Treatment1 Intervention

All patients will be treated with oral quercetin.

Quercetin is already approved in United States for the following indications:

🇺🇸 Approved in United States as Quercetin for: