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Anti-metabolites
Oral DNA Demethylating Agent for Mesothelioma
Phase 2
Recruiting
Led By David S Schrump, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate pulmonary reserve evidenced by FEV1 and DLCO >= 35% predicted on screening pulmonary function testing (PFTs)
Histologically confirmed by NCI LP subclinical, early-stage (Tx-T1) mesotheliomas
Must not have
History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before each cycle, after every 6 treatment cycles (course 1 and course 2), and at the safety visit
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug to treat BAP1 CPDS and early-stage mesothelioma. It will measure safety, progression-free survival, and stability/improvement.
Who is the study for?
This trial is for adults with BAP1 Cancer Predisposition Syndrome and early-stage mesothelioma who haven't received certain treatments. They must be able to perform daily activities with minimal assistance, agree to use contraception, and undergo specific procedures to assess treatment response. Excluded are those with recent significant cardiovascular events, active infections like COVID or hepatitis, HIV/AIDS-related illness, pregnancy, or on immunosuppressants.
What is being tested?
The study tests the effectiveness of an oral medication called INQOVI (decitabine/cedazuridine) in stabilizing or improving subclinical mesothelioma in patients predisposed due to BAP1 mutations. It measures how long patients live without disease progression and evaluates the safety of this treatment.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of decitabine/cedazuridine may include fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems. Specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function tests show I have enough breathing capacity.
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My mesothelioma is in an early stage and confirmed by a biopsy.
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My cancer is not extensive enough for standard treatments like surgery or chemotherapy.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My disease was confirmed through a minimally invasive video procedure.
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I have a genetic mutation in the BAP1 gene.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of HIV or AIDS-related illness.
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I haven't had a stroke, heart attack, severe chest pain, serious heart failure, dangerous irregular heartbeat, significant bleeding, or a serious blood clot in the lungs in the last 6 months.
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I currently have COVID-19.
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I haven't taken immune-weakening medications in the last 4 weeks, except for non-systemic corticosteroids.
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I am currently being treated for an active infection.
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I have been treated with a drug that changes DNA activity before.
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I have not taken blood thinners in the last 2 weeks.
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My cancer needs immediate standard treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before each cycle, after every 6 treatment cycles (course 1 and course 2), and at the safety visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before each cycle, after every 6 treatment cycles (course 1 and course 2), and at the safety visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine stabilization or disease improvement rates in participants with early-stage mesotheliomas arising in the context of BAP1 CPDS following decitabine/cedazuridine treatment
Secondary study objectives
To determine PFS in participants receiving decitabine/cedazuridine
To evaluate the safety of decitabine/cedazuridine
Side effects data
From 2022 Phase 2 trial • 14 Patients • NCT0405584457%
Febrile neutropenia
57%
Neutrophil count decreased
21%
Sepsis
21%
Infections and infestations - Other, specify
21%
Lung infection
21%
Bacteremia
14%
Alanine aminotransferase increased
14%
Aspartate aminotransferase increased
14%
Infections and infestations - Other,
7%
Pericardial effusion
7%
INR increased
7%
Intracranial hemorrhage
7%
Sinusitis
7%
Blood and lymphatic system
7%
Upper gastrointestinal
7%
Tooth infection
7%
Hepatic infection
7%
Blood and lymphatic system disorders - Other, specify
7%
Typhlitis
7%
Alanine aminotransferase
7%
Fatigue
7%
General disorders and administration
7%
Disease progression
7%
General disorders and administration site conditions - Other, specify
7%
Syncope
7%
Hepatobiliary disorders
7%
Skin and subcutaneous tissue disorders - Other, specify
7%
Gastrointestinal disorders - Other,
7%
Injury, poisoning and procedural
7%
Neoplasms benign, malignant and
7%
Hypertension
7%
White blood cell decreased
7%
Mucositis oral
7%
Upper gastrointestinal hemorrhage
7%
Fever
7%
Encephalopathy
7%
Hepatic failure
7%
Hyperglycemia
7%
Gastrointestinal disorders - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
Decitabine + Ruxolitinib + DLI
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/ Arm 1Experimental Treatment1 Intervention
Decitabine/cedazuridine (35 mg decitabine and 100 mg cedazuridine; PO QD)
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,450 Total Patients Enrolled
94 Trials studying Mesothelioma
8,616 Patients Enrolled for Mesothelioma
David S Schrump, M.D.Principal InvestigatorNational Cancer Institute (NCI)
19 Previous Clinical Trials
2,174 Total Patients Enrolled
11 Trials studying Mesothelioma
2,054 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function tests show I have enough breathing capacity.I am breastfeeding but willing to stop from the start of the study until 2 weeks after the last dose.If you are a woman who could become pregnant, you have a positive pregnancy test.My mesothelioma is in an early stage and confirmed by a biopsy.Your oxygen levels are at least 92% when measured with a pulse oximeter or arterial blood gas test.I have a history of HIV or AIDS-related illness.I have early-stage BAP1-related cancer, possibly including mesothelioma.My cancer is not extensive enough for standard treatments like surgery or chemotherapy.I agree to join other studies for my condition as recommended.I haven't had a stroke, heart attack, severe chest pain, serious heart failure, dangerous irregular heartbeat, significant bleeding, or a serious blood clot in the lungs in the last 6 months.I currently have COVID-19.I am fully active or can carry out light work.I agree to use effective birth control during and up to 6 months after the study.I am willing to have minor surgeries to check how well the treatment is working.I haven't taken immune-weakening medications in the last 4 weeks, except for non-systemic corticosteroids.I am currently being treated for an active infection.I do not have any health issues that would stop me from following the study's requirements.I am 18 years old or older.My kidney, liver, and blood functions are all within normal ranges.I have been treated with a drug that changes DNA activity before.I have not taken blood thinners in the last 2 weeks.My cancer needs immediate standard treatment.You currently have Hepatitis A, Hepatitis B, or Hepatitis C.My disease was confirmed through a minimally invasive video procedure.I have a genetic mutation in the BAP1 gene.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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