Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia

Squamous Cell Carcinoma Clinical Trial

Official title:

Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03476330
• Other study ID #: 2018-0073
• Secondary ID: 6353
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 8, 2018
• Est. completion date: October 2026

Study information

• Verified date: October 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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). Currently, the only curative treatment option for the hematological complications of FA include hematopoietic cell transplantation (HCT). 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.

This study is an open-label, single arm study. This study will enroll approximately 45 post-HCT patients with FA, and approximately 10 patients with FA without history of HCT. In both groups, patients with or without existing pre-malignant lesions or history of SCC will be allowed to participate, if they wish so and at the discretion of the PI. All patients will be treated with oral quercetin.

The investigators will determine the efficacy of Quercetin in reducing buccal micronuclei (a surrogate marker of DNA damage and susceptibility to squamous cell carcinoma due to genomic instability) in post-HCT patients with fanconi anemia (FA).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Carcinoma
• Carcinoma, Squamous Cell
• Fanconi Anemia
• Fanconi Syndrome
• Squamous Cell Carcinoma

Intervention

Drug:
• Quercetin (dietary supplement)
Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of buccal micronuclei	Efficacy of Quercetin in reducing buccal micronuclei	Up to 30 months