NCT01997190

Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

A Phase I Study of Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Candel Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The goal of this open-label, dose escalation clinical trial is to investigate if the administration of AdV-tk to patients with MPE followed by valacyclovir and chemotherapy is safe, can be effectively delivered without disturbing standard therapy, and will have anti-tumor activity in patients with solid tumors. The first and second dose levels have been completed, and the study is currently expanded to enroll more patients to dose level 2 with Celecoxib. Patients will receive one injection of AdV-tk through a pleural catheter on day 0. The prodrug, valacyclovir, will be administered orally at a fixed dose for 14 days after each AdV-tk injection. Celecoxib will be administered starting 3 days before AdV-tk and continuing for 2 days after AdV-tk administration. Chemotherapy may begin at any time after completion of valacyclovir. Choice of chemotherapy depends on the treating oncologist.

Conditions

• Malignant Pleural Effusion
• Lung Cancer
• Mesothelioma
• Breast Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AdV-tk + valacyclovir	AdV-tk will be administered intrapleural through pleural catheter followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-12-01
• Completion: 2018-02-01
• First posted: 2013-11-28
• Last updated: 2023-08-25

Locations

1 site across 1 country: United States