- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01766739
Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma
February 8, 2024 updated by: Memorial Sloan Kettering Cancer Center
Phase I Study of Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma
The purpose of this study is to test the safety of the GL-ONC1 vaccinia virus at different dose levels.
The investigators want to find out what effects, good and/or bad, it has on the patient and the malignant pleural effusion.
A malignant pleural effusion is a build up of fluid in the chest cavity cause by the cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GL-ONC1
This is an open-label, dose-escalating, non-randomized, single-center Phase I therapeutic study of GL-ONC1 originally administered intrapleurally as a single dose and now escalating to three consecutive daily doses in patients with a diagnosis (histologically or cytologically documented) of malignant pleural effusions.
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Patients will be enrolled in groups of three and individually assessed for safety and dose limiting toxicity (DLT).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD)
Time Frame: 2 years
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MTD is to provide a dosing recommendation for subsequent Phase II studies.
Three patients will be enrolled in each cohort at the dose levels shown in the table below in order to determine the Maximum Tolerated Dose (MTD).
At the beginning of a new dose level, only one patient will be treated.
The first patient in each cohort must be treated and complete 14 days of post-treatment evaluation prior to the treatment of the remaining two patients in that cohort.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety
Time Frame: 2 years
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The safety, tolerability and feasibility of GL-ONC1 will be assessed by the evaluation of the type, frequency, and severity of adverse events (AEs), changes in clinical laboratory tests (hematological and chemistry), immunogenicity and physical examination.
All AEs and laboratory toxicities will be graded on the CTCAE (version 4).
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2 years
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detection of virus in body fluids
Time Frame: days 2, 3, 4, & 5. pretreatment
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Patients will undergo serial sampling of blood, sputum, urine samples and pleural drainage for evaluation of viral particles by VPA immediately before treatment, and on days 2, 3, 4 and 5 pretreatment.
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days 2, 3, 4, & 5. pretreatment
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evaluation of viral appearance in tumor
Time Frame: 2-9 days after intrapleural instillation of virus
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Unless medically contraindicated, patients will undergo Video-Assisted Thoracic Surgery (VATS) with pleural biopsies to assess for green fluorescent protein (GFP) viral expression in tumor and surrounding tissues, and if appropriate, to perform pleurodesis at 2-7 days after intrapleural instillation of virus.
Random pleural biopsies and GFP-directed biopsies will be performed to allow for assessment of viral presence.
Viral plaque assays (VPA) will be performed in tumor biopsies.
Immunohistochemical (IHC) and beta-glucuronidase assay staining for GL-ONC1 will be performed on both GFP (-) and (+) areas at videothoracoscopy (if applicable).
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2-9 days after intrapleural instillation of virus
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Therapeutic efficacy
Time Frame: day 60 post treatment (+/-10 days)
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Therapeutic efficacy will be investigated with CT scans pretreatment and at Day 60 (+/-10) posttreatment.
Response by RECIST criteria (and by modified RECIST - for mesothelioma tumors) will be summarized for each dose level using descriptive statistics.
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day 60 post treatment (+/-10 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Valerie Rusch, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 Major Dates
Study Start
January 1, 2013
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
January 9, 2013
First Submitted That Met QC Criteria
January 9, 2013
First Posted (Estimated)
January 11, 2013
Study Record Updates
Last Update Posted (Estimated)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pleural Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- DNA Virus Infections
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Poxviridae Infections
- Mesothelioma
- Pleural Effusion, Malignant
- Pleural Effusion
- Vaccinia
Other Study ID Numbers
- 12-169
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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