Phase
Condition
Lung Cancer
Mesothelioma
Treatment
Decitabine/cedazuridine
Clinical Study ID
Ages 18-120 All Genders
Study Summary
Eligibility Criteria
Inclusion
INCLUSION CRITERIA:
Participants with history of germline BRCA1-Associated Protein-1 (BAP1) mutations.
Histologically confirmed by NCI LP subclinical, early-stage (Tx-T1) mesotheliomas.
Participants with other early-stage BAP1-associated malignancies in addition tosubclinical, early-stage mesotheliomas are eligible for study.
The extent of the disease (Tx by radiographic imaging) must be insufficient towarrant approved front-line therapies (surgery, chemotherapy, immunotherapy) perstandard of care (SOC). Participants with cT1 tumors may be eligible for study ifthey have been offered and have refused front-line SOC treatment.
Age >= 18 years.
Evaluable disease as confirmed by minimally invasive (videoscopic) assessment (thoracoscopy and/or laparoscopy) performed at screening (within 8 weeks prior totreatment initiation).
Willingness to undergo pre- and post-treatment minimally invasive thoracoscopyand/or laparoscopy to assess treatment response.
Willingness to co-enroll on 20C0106 (Prospective Evaluation of High Resolution DualEnergy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and MinimallyInvasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients withBAP1 Tumor Predisposition Syndrome) and/or 06C0014 (Prospective Evaluation ofGenetic and Epigenetic Alterations in Patients with Thoracic Malignancies) to enablecollection/processing of tumor, blood and normal pleura if applicable per PI.
ECOG performance status 0 - 1
Adequate pulmonary reserve evidenced by FEV1 and DLCO >= 35% predicted on screeningpulmonary function testing (PFTs).
Oxygen saturation >= 92% on room air by pulse oximetry at screening.
Adequate renal, hepatic, and hematopoietic function at screening as defined below:
leukocytes >= 3,000/microL
absolute neutrophil count >= 1,500/microL (without transfusion or cytokinesupport within 2 months prior to study treatment initiation)
absolute lymphocyte count > 800/microL
platelets >=100,000/microL and < 1,200,000/microL
prothrombin time (PT) <=2 seconds above the upper limit of normal (ULN)
total bilirubin < 1.5 X institutional upper limit of normal OR direct bilirubin <= 1 ULN for participants with total bilirubin > 1.5 ULN
serum albumin >= 2.0 mg/dL
aspartate aminotransferase (AST) / alanine aminotransferase (ALT) <= 2.5 Xinstitutional ULN
creatinine <= 1.6 mg/ml OR creatinine clearance (eGFR) >= 60 mL/min/1.73 m^2for participants with creatinine levels above institutional normal.
Individuals of child-bearing potential (IOCBP) and those that can father childrenmust agree to use an effective method of contraception (barrier, hormonal,intrauterine device (IUD), surgical sterilization) from the study entry and up to 6months (IOCBP) or 3 months (those that can father children) after the last dose ofthe decitabine/cedazuridine.
Nursing (including breastfeeding) participants must be willing to discontinuenursing from study treatment initiation through 2 weeks after the last dose of thestudy drug.
The ability of a participant to understand and the willingness to sign a writteninformed consent document.
Exclusion
EXCLUSION CRITERIA:
Participants with cancers requiring frontline standard of care treatment.
Clinically significant cardiovascular/cerebrovascular disease as follows: cerebralvascular accident/stroke (< 6 months prior to study treatment initiation),myocardial infarction (< 6 months prior to study treatment initiation), unstableangina, congestive heart failure (New York Heart Association Classification Class >=II, serious cardiac arrhythmia, clinically significant bleeding or clinicallysignificant pulmonary embolism.
Therapeutic anticoagulation within 2 weeks prior to study treatment initiation.
Active Hepatitis A (HAV), Hepatitis B (HBV) (e.g., HBsAg reactive), or Hepatitis C (HCV) (e.g., HCV RNA [qualitative] is detected) at screening.
History of human immunodeficiency virus (HIV) infection or acquired immunodeficiencysyndrome (AIDS)-related illness.
Other active infections requiring systemic therapy.
Active COVID infection.
Major surgery within 4 weeks prior to study treatment initiation.
Immunosuppressive medications within 4 weeks prior to study treatment initiationexcept non-systemic corticosteroids.
History of prior treatment with a DNA demethylating agent.
Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum orurine pregnancy test performed in IOCBP at screening).
Uncontrolled intercurrent illness or situation that would limit compliance withstudy requirements.
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesActive - Recruiting


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