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Cancer Vaccine
Hiltonol® Vaccine for Mesothelioma
Phase 1
Recruiting
Research Sponsored by Oncovir, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy proven MPM
If biopsied at an outside institution, must have a tissue block sample available
Must not have
Concomitant comorbidities that are uncontrolled that would preclude the patient from being a surgical candidate including uncontrolled CHF, diabetes or heart disease
Subject has known active Hepatitis B, Hepatitis C or tuberculosis. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27days
Awards & highlights
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.
Who is the study for?
This trial is for adults with biopsy-proven malignant pleural mesothelioma that can be surgically removed. Participants must have normal liver, kidney, and blood function, not be on certain anticoagulants or have severe bleeding risks. They cannot join if they've had organ transplants, active infections like HIV or hepatitis B/C, uncontrolled heart disease or diabetes, are pregnant/breastfeeding, or have been treated for autoimmune diseases within the last 2 years.
What is being tested?
The study tests the safety and potential effectiveness of a vaccine called poly-ICLC (Hiltonol®), injected directly into the cancerous area during biopsy up to three weeks before surgical removal of the cancer.
What are the potential side effects?
While specific side effects aren't listed here, common reactions to vaccines like poly-ICLC may include pain at injection site, fever, fatigue, headache and muscle pain. The trial specifically aims to assess these types of safety concerns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of mesothelioma was confirmed through a biopsy.
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I can provide a tissue sample from my biopsy done elsewhere.
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A thoracic surgeon has confirmed I can have surgery to remove my tumor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled health issues like heart failure, diabetes, or heart disease.
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I have active Hepatitis B, Hepatitis C, or tuberculosis.
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I cannot safely undergo a lung biopsy due to my lung condition.
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I am currently being treated for an infection.
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I am not pregnant, breastfeeding, or have a positive pregnancy test.
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I have received an organ or tissue transplant from another person.
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I have severe pulmonary hypertension or a history of it.
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I do not have a serious illness or infection that would make treatment unsafe for me.
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The probability of rejecting the investigational treatment is at least 81%, if the DLT rate is greater than 33% and the probability of accepting the treatment is at least 71% if the DLT rate is less than a safe level of 17%.
Secondary study objectives
Objective response rate by RECIST 1.1 using CT imaging.
Trial Design
2Treatment groups
Experimental Treatment
Group I: SafetyExperimental Treatment1 Intervention
Six patients will be enrolled in the Phase 1 safety cohort. Patients will have an IR guided biopsy and FNA. Up to four core biopsies and FNAs at one site will be performed prior to intratumoral (IT) administration of Poly-ICLC. Pleural fluid will be collected for research analysis if available. Poly-ICLC will be injected in 2 locations within the pleura. Patients will undergo surgery 21±7 days after the biopsy and Poly-ICLC intratumoral (IT) injection. The type of surgery that will be performed is at the discretion of the thoracic surgeon and per the standard of care. This includes pleurectomy/decortication or extrapleural pneumonectomy. Patients will be evaluated per the standard of care post-operatively. On day 7±4 days a final toxicity assessment, physical exam and research blood will be collected. All post-operative care and monitoring thereafter is as per standard of care.
Group II: Expansion CohortExperimental Treatment1 Intervention
If at most one (1) patient in the Phase 1 safety cohort experiences a DLT then a total of thirteen (13) additional patients will be enrolled into the Phase 1b Expansion Cohort. Patients in the Expansion Cohort will receive the same dose and schedule of Poly-ICLC as in the Phase 1 safety cohort. Patients will be followed for safety and tolerability, as well as efficacy. If a total of 4 or more patients experience DLTs then the study will be closed due to excessive toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Safety
2014
N/A
~560
Find a Location
Who is running the clinical trial?
Oncovir, Inc.Lead Sponsor
23 Previous Clinical Trials
640 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
886 Previous Clinical Trials
535,024 Total Patients Enrolled
Thomas Marron, MDStudy DirectorAssistant Director
3 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Safety
- Group 2: Expansion Cohort
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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