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 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 Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Study Arm
AdV-tk administered intrapleural through pleural catheter followed by oral valacyclovir.
Biological: AdV-tk + valacyclovir
Three dose levels of AdV-tk will be evaluated. 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.
Three dose levels of AdV-tk will be evaluated. The first two dose levels will receive one injection of AdV-tk through a pleural catheter on day 0. Dose level 3 will receive 2 injections of AdV-tk. Timing for the second administration for dose level 3 will be decided based on the data obtained from dose level 1 and 2. The prodrug, valacyclovir, will be administered orally at a fixed dose for 14 days after each AdV-tk injection. At Level 3, valacyclovir will be administered after the first AdV-tk administration until 14 days after the second administration of AdV-tk.
Chemotherapy may begin at any time after completion of valacyclovir. Choice of chemotherapy depends on the treating oncologist.
|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|