Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
54

Inclusion Criteria

ECOG Zubrod ≤ 2.
Bilirubin ≤ 1.5 × ULN,
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.
...
ECOG Zubrod ≤ 2.
Bilirubin ≤ 1.5 × ULN,
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.
AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases)
Any surgery, where general anesthesia was administered, must have occurred at least 14 days prior to study enrollment.
Age must be ≥ 18 years.
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.
Serum creatinine ≤ 1.5 × upper limit of normal (ULN),
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.
Platelets ≥ 100 ×10^9 [SI units 10^9/L],
Absolute neutrophil count (ANC) ≥ 1.5 × 109 [SI units 10^9/L],
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.
Negative pregnancy test for females of childbearing potential.
Required baseline laboratory data include:
Hemoglobin ≥ 9.0 g/dL [SI units gm/L],

Exclusion Criteria

Patients with clinically significant dermatological disorders, e.g., eczema or psoriasis, as judged by the principal investigator, or any unhealed skin wounds or ulcers.
Prior splenectomy.
Pregnant or breast-feeding women.
...
Patients with clinically significant dermatological disorders, e.g., eczema or psoriasis, as judged by the principal investigator, or any unhealed skin wounds or ulcers.
Prior splenectomy.
Pregnant or breast-feeding women.
Patients on immunosuppressive therapy or with immune system disorders, including autoimmune diseases.
Clinically significant cardiac disease (New York Heart Association, Class III or IV).
Previous organ transplant.
Known allergy to ovalbumin or other egg products.
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.
Dementia or altered mental status that would prohibit informed consent.
Prior gene therapy treatments or prior therapy with cytolytic virus of any type.
Concurrent therapy with any other investigational anticancer agent.
Patients with fever or any active systemic infections, including known HIV, hepatitis B or C.
Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia immunoglobulin) during the study.
Concurrent steroid use of more than an equivalent of 20 mg/day prednisone (or equivalent).

Summary

Conditions
Lung Cancer
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

ECOG Zubrod ≤ 2.
Bilirubin ≤ 1.5 × ULN,
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.
...
ECOG Zubrod ≤ 2.
Bilirubin ≤ 1.5 × ULN,
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.
AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases)
Any surgery, where general anesthesia was administered, must have occurred at least 14 days prior to study enrollment.
Age must be ≥ 18 years.
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.
Serum creatinine ≤ 1.5 × upper limit of normal (ULN),
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.
Platelets ≥ 100 ×10^9 [SI units 10^9/L],
Absolute neutrophil count (ANC) ≥ 1.5 × 109 [SI units 10^9/L],
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.
Negative pregnancy test for females of childbearing potential.
Required baseline laboratory data include:
Hemoglobin ≥ 9.0 g/dL [SI units gm/L],

Exclusion Criteria

Patients with clinically significant dermatological disorders, e.g., eczema or psoriasis, as judged by the principal investigator, or any unhealed skin wounds or ulcers.
Prior splenectomy.
Pregnant or breast-feeding women.
...
Patients with clinically significant dermatological disorders, e.g., eczema or psoriasis, as judged by the principal investigator, or any unhealed skin wounds or ulcers.
Prior splenectomy.
Pregnant or breast-feeding women.
Patients on immunosuppressive therapy or with immune system disorders, including autoimmune diseases.
Clinically significant cardiac disease (New York Heart Association, Class III or IV).
Previous organ transplant.
Known allergy to ovalbumin or other egg products.
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.
Dementia or altered mental status that would prohibit informed consent.
Prior gene therapy treatments or prior therapy with cytolytic virus of any type.
Concurrent therapy with any other investigational anticancer agent.
Patients with fever or any active systemic infections, including known HIV, hepatitis B or C.
Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia immunoglobulin) during the study.
Concurrent steroid use of more than an equivalent of 20 mg/day prednisone (or equivalent).

Tracking Information

NCT #
NCT01766739
Collaborators
Genelux Corporation
Investigators
  • Principal Investigator: Valerie Rusch, MD Memorial Sloan Kettering Cancer Center
  • Valerie Rusch, MD Memorial Sloan Kettering Cancer Center
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