COMPLETED

Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

Conditions

Malignant Pleural Mesothelioma Malignant Pleural Mesothelioma (MPMV Vaccine Poly-ICLC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

Quick Facts

Study Start:2020-08-19

Study Completion:2025-06-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04525859

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Biopsy proven MPM 2. Deemed to be surgically resectable by a dedicated thoracic surgeon. 3. Acceptable hematologic, renal and liver function as follows: * Absolute neutrophil count \> 1000/mm3 * Platelets \> 50,000/mm3, * Creatinine ≤ 2.5 mg/dl, * Total bilirubin ≤ 1.5 mg/dl, unless patient has known Gilberts syndrome * Transaminases ≤ 2 times above the upper limits of the institutional normal. * INR\<1.6 if off of anticoagulation. Patients on anticoagulation therapy with an INR\>1.6 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage and if the site to be injected is fully surrounded by pleura where achieving homeostasis would be complicated. 4. Patient must be able to provide informed consent 5. Subject is willing to adhere to the study visit schedule and other protocol requirements.	1. Serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive Poly-ICLC with reasonable safety. 2. History of any pulmonary process that precludes a biopsy to be done safely. 3. Known severe pulmonary hypertension; having a history of pulmonary hypertension or an estimated PA systolic pressure of \>60mmHg as measured by tricuspid regurgitation on preoperative echocardiogram. 4. Subject unable to cooperate in terms of maintaining position during the biopsy procedure. 5. AIDS defined as a CD4 count less than 200 in the context of HIV seropositivity or chronically is taking immunosuppressive medication such as steroids or transplant related medications. 6. Persistent toxicity from recent therapy that has not sufficiently resolved in the judgment of the study physician. 7. Subject has an active infection requiring therapy. 8. Subject has had an allogeneic tissue/solid organ transplant. 9. Subject has active autoimmune disease that has required systemic treatment within the past 2 years (eg, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 10. 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. 11. Concomitant comorbidities that are uncontrolled that would preclude the patient from being a surgical candidate including uncontrolled CHF, diabetes or heart disease 12. Women with a positive serum or urine pregnancy test at baseline, or are pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

1. Biopsy proven MPM
2. Deemed to be surgically resectable by a dedicated thoracic surgeon.
3. Acceptable hematologic, renal and liver function as follows:
* Absolute neutrophil count \> 1000/mm3
* Platelets \> 50,000/mm3,
* Creatinine ≤ 2.5 mg/dl,
* Total bilirubin ≤ 1.5 mg/dl, unless patient has known Gilberts syndrome
* Transaminases ≤ 2 times above the upper limits of the institutional normal.
* INR\<1.6 if off of anticoagulation. Patients on anticoagulation therapy with an INR\>1.6 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage and if the site to be injected is fully surrounded by pleura where achieving homeostasis would be complicated.
4. Patient must be able to provide informed consent
5. Subject is willing to adhere to the study visit schedule and other protocol requirements.

1. Serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive Poly-ICLC with reasonable safety.
2. History of any pulmonary process that precludes a biopsy to be done safely.
3. Known severe pulmonary hypertension; having a history of pulmonary hypertension or an estimated PA systolic pressure of \>60mmHg as measured by tricuspid regurgitation on preoperative echocardiogram.
4. Subject unable to cooperate in terms of maintaining position during the biopsy procedure.
5. AIDS defined as a CD4 count less than 200 in the context of HIV seropositivity or chronically is taking immunosuppressive medication such as steroids or transplant related medications.
6. Persistent toxicity from recent therapy that has not sufficiently resolved in the judgment of the study physician.
7. Subject has an active infection requiring therapy.
8. Subject has had an allogeneic tissue/solid organ transplant.
9. Subject has active autoimmune disease that has required systemic treatment within the past 2 years (eg, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
10. 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.
11. Concomitant comorbidities that are uncontrolled that would preclude the patient from being a surgical candidate including uncontrolled CHF, diabetes or heart disease
12. Women with a positive serum or urine pregnancy test at baseline, or are pregnant or breastfeeding.

Contacts and Locations

Principal Investigator

Thomas Marron, MD

STUDY_DIRECTOR

Assistant Director

Study Locations (Sites)

Icahn School of Medicine Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Oncovir, Inc.

Thomas Marron, MD, STUDY_DIRECTOR, Assistant Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-19

Study Completion Date2025-06-18

Study Record Updates

Study Start Date2020-08-19

Study Completion Date2025-06-18

Terms related to this study

Keywords Provided by Researchers

Malignant Pleural Mesothelioma (MPMV
Vaccine
Poly-ICLC

Additional Relevant MeSH Terms

Malignant Pleural Mesothelioma