Hiltonol® Vaccine for Mesothelioma

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Oncovir, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will examine the safety and potential effectiveness of poly-ICLC directly injected into malignant pleural mesothelioma at the time of biopsy up to 21 days prior to the cancer being removed by the surgeon

Eligibility Criteria

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.

Inclusion Criteria

My diagnosis of mesothelioma was confirmed through a biopsy.

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.

+9 more

Exclusion Criteria

I do not have uncontrolled health issues like heart failure, diabetes, or heart disease.

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

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

+9 more

Participant Groups

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.

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.