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Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia

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ClinicalTrials.gov Identifier: NCT03476330
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Fanconi Anemia Squamous Cell Carcinoma Drug: Quercetin (dietary supplement) Phase 2

Detailed 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 38 post-HCT patients with FA, and up to 7 patients with FA without history of HCT. In both groups, patients with or without evidence of any pre-malignant lesions concerning for SCC, history of SCC or active SCC may be allowed to participate if they wish so and at the discretion of the PI. All patients will be treated with oral quercetin for a total of 24 months.

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Experimental: Quercetin
All patients will be treated with oral quercetin for a total of 24 months.
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.




Primary Outcome Measures :
  1. Reduction of buccal micronuclei [ Time Frame: Up to 30 months ]
    Efficacy of Quercetin in reducing buccal micronuclei



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476330


Contacts
Contact: Stephanie A Edwards, BSN, RN 513-636-9292 StephanieL.Edwards@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Stephanie L Edwards, BSN, RN    513-636-9292    StephanieL.Edwards@cchmc.org   
Principal Investigator: Parinda A Mehta, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Parinda A Mehta, MD Cincinnati Children's Hosptial Medical Center

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03476330     History of Changes
Other Study ID Numbers: 2018-0073
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Hematopoietic cell transplantation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Anemia
Fanconi Anemia
Fanconi Syndrome
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Hematologic Diseases
Anemia, Hypoplastic, Congenital
Anemia, Aplastic
Bone Marrow Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs