Clinical trial: Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma (NCT01766739)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of histologically or cytologically documented, malignant pleural effusions
             (primary non-small-cell lung carcinoma, mesothelioma, and other histologies), who have
             free pleural space (partial or total) that permits the intrapleural drug instillation.
             This includes cytologically negative pleural effusion in conjunction with
             histologically proven malignancy involving the pleura.

          -  Age must be ≥ 18 years.

          -  All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical
             procedures must have resolved to Common Terminology Criteria for Adverse Events
             (CTCAE, Version 4.0) Grade ≤ 1.

          -  Any surgery, where general anesthesia was administered, must have occurred at least 14
             days prior to study enrollment.

          -  Chemotherapy, radiotherapy or immunotherapy must have stopped more than 7 days prior
             to receiving study drug; however, small field palliative radiotherapy, TKI therapies
             and hormonal therapies are allowed.

          -  Patients with stage IV malignancy (non-mesothelioma) must have had a brain scan (MRI
             or CT with contrast) showing no evidence of disease progression within 8 weeks of
             study enrollment.

          -  ECOG Zubrod ≤ 2.

          -  Required baseline laboratory data include:

          -  Absolute neutrophil count (ANC) ≥ 1.5 × 109 [SI units 10^9/L],

          -  Platelets ≥ 100 ×10^9 [SI units 10^9/L],

          -  Hemoglobin ≥ 9.0 g/dL [SI units gm/L],

          -  Serum creatinine ≤ 1.5 × upper limit of normal (ULN),

          -  Bilirubin ≤ 1.5 × ULN,

          -  AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases)

          -  Negative pregnancy test for females of childbearing potential.

        Exclusion Criteria:

          -  Pregnant or breast-feeding women.

          -  Patients with fever or any active systemic infections, including known HIV, hepatitis
             B or C.

          -  Patients on immunosuppressive therapy or with immune system disorders, including
             autoimmune diseases.

          -  Concurrent steroid use of more than an equivalent of 20 mg/day prednisone (or
             equivalent).

          -  Prior splenectomy.

          -  Previous organ transplant.

          -  Patients with clinically significant dermatological disorders, e.g., eczema or
             psoriasis, as judged by the principal investigator, or any unhealed skin wounds or
             ulcers.

          -  Clinically significant cardiac disease (New York Heart Association, Class III or IV).

          -  Dementia or altered mental status that would prohibit informed consent.

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality, that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results and, in
             the judgment of the principal investigator, would make the patient inappropriate for
             this study.

          -  Known allergy to ovalbumin or other egg products.

          -  Prior gene therapy treatments or prior therapy with cytolytic virus of any type.

          -  Concurrent therapy with any other investigational anticancer agent.

          -  Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia
             immunoglobulin) during the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment