← Back to Search

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

No Placebo-Only Group

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 below

Select...

My diagnosis of mesothelioma was confirmed through a biopsy.

Select...

I can provide a tissue sample from my biopsy done elsewhere.

Select...

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.

Select...

I have active Hepatitis B, Hepatitis C, or tuberculosis.

Select...

I cannot safely undergo a lung biopsy due to my lung condition.

Select...

I am currently being treated for an infection.

Select...

I am not pregnant, breastfeeding, or have a positive pregnancy test.

Select...

I have received an organ or tissue transplant from another person.

Select...

I have severe pulmonary hypertension or a history of it.

Select...

I do not have a serious illness or infection that would make treatment unsafe for me.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27days for reporting.

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met