Is NCT05960773 recruiting in Bethesda, MD?

Yes, NCT05960773 is currently recruiting participants at its Bethesda, MD location. This mesothelioma clinical trial is actively enrolling qualified participants.

How do I join the mesothelioma clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Mesothelioma Clinical Trial in Bethesda, MD

About This Mesothelioma Study in Bethesda

This is a Phase II study to determine the rate of stabilization or disease improvement from investigational decitabine/cedazuridine (INQOVI) treatment in subjects with BRCA1-Associated Protein-1 (BAP1) Cancer Predisposition Syndrome (CPDS) and subclinical, early-stage mesothelioma. Progression-free survival (PFS) will also be determined for treated subjects, and the treatment safety (toxicity) evaluated....

Sponsor: National Cancer Institute (NCI)

Who Can Participate

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 to subclinical, early-stage mesotheliomas are eligible for study.

The extent of the disease (Tx by radiographic imaging) must be insufficient to warrant approved front-line therapies (surgery, chemotherapy, immunotherapy) per standard of care (SOC). Participants with cT1 tumors may be eligible for study if they 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 to treatment initiation).

Willingness to undergo pre- and post-treatment minimally invasive thoracoscopy and/or laparoscopy to assess treatment response.

Willingness to co-enroll on 20C0106 (Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients with BAP1 Tumor Predisposition Syndrome) and/or 06C0014 (Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies) to enable collection/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 screening pulmonary 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 cytokine support 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 X institutional ULN

creatinine \<= 1.6 mg/ml OR creatinine clearance (eGFR) \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal.

Individuals of child-bearing potential (IOCBP) and those that can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization) from the study entry and up to 6 months (IOCBP) or 3 months (those that can father children) after the last dose of the decitabine/cedazuridine.

Nursing (including breastfeeding) participants must be willing to discontinue nursing from study treatment initiation through 2 weeks after the last dose of the study drug.

The ability of a participant to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Participants with cancers requiring frontline standard of care treatment.

Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (\< 6 months prior to study treatment initiation), myocardial infarction (\< 6 months prior to study treatment initiation), unstable angina, congestive heart failure (New York Heart Association Classification Class \>= II, serious cardiac arrhythmia, clinically significant bleeding or clinically significant 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 immunodeficiency syndrome (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 initiation except non-systemic corticosteroids.

History of prior treatment with a DNA demethylating agent.

Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in IOCBP at screening).

Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT05960773) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mesothelioma Treatment Options in Bethesda, MD

If you're searching for mesothelioma treatment options in Bethesda, MD, this clinical trial (NCT05960773) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced mesothelioma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mesothelioma clinical trials near you to find additional studies recruiting in your area.

Mesothelioma Clinical Trial in Bethesda, MD

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