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rAd-IFN + Celecoxib + Gemcitabine for Mesothelioma (INFINITE Trial)
INFINITE Trial Summary
This trial will compare the overall survival of patients with mesothelioma who receive a combination of adenovirus-delivered interferon alpha-2b, celecoxib, and gemcitabine versus celecoxib and gemcitabine alone.
INFINITE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowINFINITE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.INFINITE Trial Design
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Who is running the clinical trial?
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- You have had problems digesting galactose or glucose in the past.My cancer has spread beyond my chest to other parts of my body.My blood pressure is very high and not well-managed.The doctor thinks you have about 12 weeks to live.I am currently taking lithium.I have a weakened immune system, including HIV.My blood tests show albumin levels are between 2.5 to 3.5 g/dL and bilirubin is high.I am fully active or restricted in physically strenuous activity but can do light work.I am a woman who cannot have children because I am postmenopausal or have been surgically sterilized.I am a male and will use double contraception from screening until 6 months after the last gemcitabine dose.I am not pregnant or breastfeeding.I have been treated with gemcitabine before.I have undergone 3 or more rounds of chemotherapy or immunotherapy.Your blood test results should show: Hemoglobin at least 9 g/dL, White blood cell count at least 3500/µL, Neutrophil count at least 1500/µL, Platelet count at least 100,000/µL, Normal INR and aPTT, AST and ALT levels not more than 3 times the upper limit of normal, Bilirubin not more than 2 times the upper limit of normal, Estimated kidney function at least 50 mL/min/1.73 m2, and Albumin at least 2.5 g/dL.I had cancer treatment less than 2 years ago or have another active cancer.You have a measurable disease according to specific guidelines for pleural mesothelioma.I have had serious bowel inflammation treated with strong medication in the last 5 years.You have a history of allergic reactions to aspirin or NSAIDs, or certain conditions like asthma and nasal polyps.My previous cancer treatments count as one line of therapy each.I am not pregnant and agree to use effective birth control during and for 1 month after the study.I am allergic to IFN-α2b, rAd-IFN, celecoxib, or gemcitabine.Your heart's electrical activity, measured by ECG, shows a prolonged QT interval.I have an autoimmune disease or require immunosuppressive medication.I am 18 years old or older.I do not have any unmanaged ongoing illnesses.You have a space in your chest where a certain medical device can be put in.A large amount of fluid around your heart was found on a CT scan.I have not received any treatment involving anti-folate and platinum.My cancer is confirmed as MPM and is mostly epithelioid.I have had ulcers or bleeding in my stomach or intestines.I've had 1 or 2 treatments for MPM, including chemo with anti-folate and platinum.I have completed all my previous treatments as required before starting the new therapy.I have heart problems that affect my daily activities.I have been treated with interferons before.My lung function is not good, as confirmed by my doctor.
- Group 1: Control Group
- Group 2: Treatment Group
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Are the methods and procedures of Treatment Group approved by the Federal Drug Administration?
"There is some evidence that the treatment is effective, and it has been through multiple rounds of testing, so the safety of the treatment is estimated to be a 3."
Have other groups of patients been treated with this method before?
"There are currently 505 ongoing clinical trials researching Treatment Group. Out of those, 141 have progressed to Phase 3. Although the majority of these studies originate from Woolloongabba, Queensland, there are 25431 total locations running these trials."
What are the benefits of participating in Treatment Group?
"The urinary bladder is often treated with drugs from the Treatment Group. Drugs in the Treatment Group are also used to manage small cell lung cancer (sclc), pain, and head and neck carcinoma."
Are there any opportunities for subjects to join this research?
"As of now, this study is not looking for more patients. The listing for this trial was first posted on January 21st, 2019 and was edited most recently on October 25th, 2021. If you are interested in other studies, there are 158 trials for patients with mesothelioma and 505 for patients in a Treatment Group."
Are there other hospitals testing this out in our state?
"In addition to University of Maryland Medical Center in Baltimore, Maryland and NYU Clinical Cancer Center in New york, New York, this clinical trial is also enrolling patients from University of Pennsylvania Abramson Cancer Center in Philadelphia, Pennsylvania and 12 other locations."
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