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

Brief Summary

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.

Tracking Information
First Received DateJanuary 9, 2013
Last Changed DateJanuary 27, 2017
Start DateJanuary 2013
Anticipated Primary Completion DateJanuary 2018
Primary Outcome Measures

Maximum Tolerated Dose (MTD) [Time Frame: 2 years]

Secondary Outcome Measures

safety [Time Frame: 2 years]

detection of virus in body fluids [Time Frame: days 2, 3, 4, & 5. pretreatment]

evaluation of viral appearance in tumor [Time Frame: 2-9 days after intrapleural instillation of virus]

Therapeutic efficacy [Time Frame: day 60 post treatment (+/-10 days)]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Lung Cancer
Intervention
  • Biological: GL-ONC1
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusActive, not recruiting
Actual Enrollment18
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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.

Administrative Information
NCTIDNCT01766739
Responsible Party,
SponsorMemorial Sloan Kettering Cancer Center
Verification DateJanuary 2017
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

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