Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAdV-tk + valacyclovir

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 25, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Candel Therapeutics, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Candel Therapeutics, Inc.
Interventions being studied: Biological: AdV-tk + valacyclovir

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Mesothelioma→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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