Phase 3 Mesothelioma Trial, Completed

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older at the time of giving consent
• People who are able to give their own informed consent to participate
• People who have a confirmed tissue-sample diagnosis of a specific type of cancer called malignant pleural mesothelioma (MPM), where the cancer cells are of the "epithelioid" type, or a mixed type that is more than half epithelioid — this diagnosis must be confirmed by the trial's central review team
• People whose cancer can be measured on scans, using specific criteria designed for this type of cancer
• People who have already received either one or two rounds of prior cancer treatment (chemotherapy and/or immunotherapy), including at least one course of a specific drug combination involving an anti-folate and a platinum-based drug
• People who have a chest cavity that allows for insertion of a drainage tube device, or who already have such a device in place that is working properly and shows no signs of infection
• People whose doctor estimates they have a life expectancy of at least 12 weeks
• People with a good general performance level, rated 0 or 1 on a standard scale used by doctors to measure how much a patient's illness affects their daily activities (where 0 means fully active and 1 means slightly limited)
• Women who could become pregnant must have a negative pregnancy test before starting and must use a highly effective form of contraception from the screening stage until one month after the last dose of a study drug called gemcitabine (confirm specific methods with trial site)
• Women who cannot become pregnant must be either post-menopausal (no periods for at least 12 months) or have had a surgical procedure that prevents pregnancy
• Men must either have had a surgical procedure that prevents them from fathering children, or must use a double-barrier contraception method from screening until six months after the last dose of gemcitabine — and where local practice allows, men may be advised to consider sperm preservation before treatment begins
• People whose blood test results at screening meet minimum levels for red blood cells, white blood cells, infection-fighting cells (neutrophils), platelets, blood clotting, liver function, kidney function, and protein levels (confirm specific values with trial site)

Who may not be able to join:

• People who have not yet received any prior cancer treatment, specifically those who have never had the anti-folate and platinum drug combination
• People who have already received three or more separate rounds of systemic cancer treatment (chemotherapy or immunotherapy)
• People who have previously been treated with a chemotherapy drug called gemcitabine
• People whose cancer has spread to areas outside the chest cavity (stage IV with spread beyond the chest)
• People whose lung function is significantly reduced, as assessed by the trial doctor
• People who have a clinically significant fluid build-up around the heart, detected on a CT scan at screening
• People who have not waited long enough since their last cancer treatment before joining — specific waiting periods apply depending on the type of treatment received (confirm exact timeframes with trial site)
• People who have previously been treated with drugs called interferons (for example, for a liver condition such as chronic active hepatitis)
• People who are known or suspected to have an allergic reaction to interferon alpha-2b or to the study's gene therapy agent (rAd-IFN), or any of their ingredients
• People with a known allergy to a drug called celecoxib or to a class of drugs called sulfonamides
• People with a known allergy to gemcitabine or any of its ingredients
• People with significant heart problems, including severe heart failure, a heart attack within the past 12 months, or reduced heart pumping function of clinical significance
• Women who are pregnant or breastfeeding
• People with uncontrolled ongoing illness, including active infections, unstable heart conditions, uncontrolled irregular heartbeat, or significant mental health conditions within the past 12 months
• People with active autoimmune diseases that require ongoing treatment with immune-suppressing medications (some exceptions may apply — confirm with trial site)
• People with a history of asthma, nasal polyps, severe allergic swelling, hives, or allergic reactions to aspirin, anti-inflammatory drugs (NSAIDs), or COX-2 inhibitor drugs
• People with a history of stomach ulcers or gastrointestinal bleeding
• People with poorly controlled high blood pressure (above 160/100 mmHg) that requires three or more blood pressure medications
• People with a specific heart rhythm measurement (QT interval) that is too prolonged, as shown on a resting heart tracing (ECG)
• People currently taking a medication called lithium
• People with any significant health condition that, in the trial doctor's opinion, would put them at increased risk of harm from participating
• People who were treated for a previous different cancer less than two years ago, still have signs of that cancer, or have another current cancer that is unstable and requires active treatment
• People with a weakened immune system due to a genetic condition, an acquired condition, or a known HIV infection
• People who have both a low blood protein (albumin) level and an elevated bilirubin level at the same time (confirm specific values with trial site)
• People with a history of significant inflammatory bowel disease that required intravenous immune-suppressing treatment within the past five years
• People with specific rare inherited conditions affecting how the body processes certain sugars (galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)

Important: Always verify eligibility with the trial site directly before applying.