Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion (MpeTK01)
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
Malignant Pleural Effusion
Biological: AdV-tk + valacyclovir
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion|
- Safety [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]The primary study endpoint for the phase I portion is safety based on standard laboratory and clinical adverse event monitoring. Safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase. Acute toxicity data will be collected at each follow up visit every 2-3 weeks until week 8. The long term effects will be evaluated at follow up visits very 3 months for 1 year, then every 6 months for the second year. After 2 years, clinical assessment of late toxicity and disease status will be conducted yearly through year 5 after which long-term follow up of general health status will continue yearly through at least 10 years.
- Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Assessed at each visit every 3 months for 1 year, then every 6 months for the second year and then at least yearly until 10 years or until disease progression.
- Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]Follow up for survival for at least 10 years.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Study Arm
AdV-tk + valacyclovir
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01997190
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadephia, Pennsylvania, United States, 19104|
|Contact: Susan Metzger 215-615-5478 Susan.Metzger@uphs.upenn.edu|
|Principal Investigator: Charu Aggarwal, MD|
|Principal Investigator:||Charu Aggarwal, MD||University of Pennsylvania|