Back to resultsIntrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion (MpeTK01)
Primary Purpose
Malignant Pleural Effusion, Lung Cancer, Mesothelioma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AdV-tk + valacyclovir
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring Immunotherapy, Gene therapy, Tumor vaccine
Eligibility Criteria
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.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Arm
Arm Description
AdV-tk + valacyclovir
Outcomes
Primary Outcome Measures
Incidence of treatment emergent adverse events
Secondary Outcome Measures
Progression-free survival
Overall survival
Full Information
NCT ID
NCT01997190
First Posted
November 19, 2013
Last Updated
August 23, 2023
Sponsor
Candel Therapeutics, Inc.
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01997190
Brief Title
Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion
Acronym
MpeTK01
Official Title
A Phase I Study of Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Candel Therapeutics, Inc.
Collaborators
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion, Lung Cancer, Mesothelioma, Breast Cancer, Ovarian Cancer
Keywords
Immunotherapy, Gene therapy, Tumor vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
AdV-tk + valacyclovir
Intervention Type
Biological
Intervention Name(s)
AdV-tk + valacyclovir
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
5 years
Title
Overall survival
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charu Aggarwal, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29550074
Citation
Aggarwal C, Haas AR, Metzger S, Aguilar LK, Aguilar-Cordova E, Manzanera AG, Gomez-Hernandez G, Katz SI, Alley EW, Evans TL, Bauml JM, Cohen RB, Langer CJ, Albelda SM, Sterman DH. Phase I Study of Intrapleural Gene-Mediated Cytotoxic Immunotherapy in Patients with Malignant Pleural Effusion. Mol Ther. 2018 May 2;26(5):1198-1205. doi: 10.1016/j.ymthe.2018.02.015. Epub 2018 Feb 21.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/29550074/
Description
Phase I Study of Intrapleural Gene-Mediated Cytotoxic Immunotherapy in Patients with Malignant Pleural Effusion
Learn more about this trial
Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion
We'll reach out to this number within 24 hrs