- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01997190
Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion (MpeTK01)
A Phase I Study of Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion 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
Exclusion 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Arm
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of treatment emergent adverse events
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 10 years
|
10 years
|
Progression-free survival
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charu Aggarwal, MD, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pleural Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Pleural Effusion, Malignant
- Pleural Effusion
- Anti-Infective Agents
- Antiviral Agents
- Valacyclovir
Other Study ID Numbers
- MpeTK01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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