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Hiltonol® Vaccine for Mesothelioma
Study Summary
This trial will test a new cancer treatment involving injecting a drug directly into mesothelioma tumors. The hope is that this will make the tumors smaller and easier to remove.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My diagnosis of mesothelioma was confirmed through a biopsy.I do not have uncontrolled health issues like heart failure, diabetes, or heart disease.I have active Hepatitis B, Hepatitis C, or tuberculosis.Your creatinine levels in the blood are less than 2.5 mg/dl.You have more than 50,000 platelets in a specific amount of blood.You have enough white blood cells to join the study.I cannot safely undergo a lung biopsy due to my lung condition.I am currently being treated for an infection.You are unable to stay still during the biopsy procedure.I am not pregnant, breastfeeding, or have a positive pregnancy test.I can provide a tissue sample from my biopsy done elsewhere.A thoracic surgeon has confirmed I can have surgery to remove my tumor.My blood, kidney, and liver tests are within normal ranges.My blood clotting time is normal or controlled if I'm on blood thinners.I have received an organ or tissue transplant from another person.Your liver enzymes are not more than twice the normal levels.You are still experiencing side effects from a recent treatment that have not gone away.Your total bilirubin level must be less than 1.5 mg/dl, unless you have Gilbert's syndrome.I have severe pulmonary hypertension or a history of it.You have a weakened immune system due to HIV or taking certain medications that weaken the immune system.I do not have a serious illness or infection that would make treatment unsafe for me.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
- Group 1: Safety
- Group 2: Expansion Cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants is the maximum capacity of this research endeavor?
"Affirmative. The records available on clinicaltrials.gov display that this trial is actively looking for test subjects, with 19 necessary to be recruited from a single site since its inception on August 19th 2020 and last update taking place March 31st 2022."
Is this research initiative presently accepting volunteers?
"Confirmed, the clinical trial is still accepting applicants. This research was first posted on August 19th 2020 and recently updated March 31st 2022 as per records on clinicaltrials.gov."
Has Safety been granted approval from the Federal Drug Administration?
"According to our internal assessment, the safety rating of this Phase 1 trial was only a 1 as there is limited data that supports its efficacy and safety."
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