Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion
This is a phase I study of intrapleural AdV-tk therapy in patients with malignant pleural effusion (MPE). The primary objective is to test the safety of intrapleural AdV-tk therapy. Secondary objectives are to evaluate clinical efficacy and biologic activity
Checked against the public recordLast updated Aug 25, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Candel Therapeutics, Inc.
- Interventions being studied
- Biological: AdV-tk + valacyclovir
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Patients must have MPE (defined as positive pleural fluid cytology). Eligible patients include NSCLC, small cell lung cancer, malignant mesothelioma (MM), breast cancer and ovarian cancer. Diagnosis must be made prior to AdV-tk injection. For patients with MM, histologic proof is needed, but positive pleural fluid cytology is not required. * Patients must have an indication for placement of pleural catheter * Patients must be 18 years of age or older * Performance status must be ECOG 0-1 * Acute toxic effects from any prior radiotherapy, chemotherapy, or prior surgical procedures must have resolved to NCI CTCAE v 4.0 grade ≤ 1 * Baseline pulmonary function tests must be FEV1 ≥1 liter or 40% of predicted value (may be post-drainage and/or bronchodilator) * Bilirubin ≤ 1.5 x upper limit of normal (ULN) and ALT, AST and alkaline phosphatase ≤ 2 x ULN * Serum creatinine \< 2 mg/dl and calculated creatinine clearance \> 30 ml/min * Hemoglobin ≥ 9 g/dL, ANC \> 1000/mm3 and platelets \> 100,000/mm3 * Serum albumin level ≥ 2.5 g/dL * Patients must give study specific informed consent prior to enrollment Exclusion Criteria: * Patients may not be on systemic corticosteroids (\>10 mg prednisone per day) or other systemic immunosuppressive drugs * Patient is not known to be HIV+ * Patient is not pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy. * Patient may not have clinically significant pericardial effusion * Patient may not have other serious co-morbid illness or compromised organ function * Patient may not have liver disease including known cirrhosis, active hepatitis or chronic active hepatitis B * No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib, aspirin or other NSAIDs * No concurrent use of other NSAID or aspirin exceeding 100mg/day during celecoxib administration. No wash-out period required.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 25, 2023. Always confirm current availability with the study team.