Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion (MpeTK01)
|ClinicalTrials.gov Identifier: NCT01997190|
Recruitment Status : Active, not recruiting
First Posted : November 28, 2013
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Effusion Lung Cancer Mesothelioma Breast Cancer Ovarian Cancer||Biological: AdV-tk + valacyclovir||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||October 2020|
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.
- Safety [ Time Frame: 8 weeks ]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 ]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 ]Follow up for survival for at least 10 years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997190
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Charu Aggarwal, MD||University of Pennsylvania|