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Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion (MpeTK01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01997190
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : December 4, 2020
University of Pennsylvania
Information provided by (Responsible Party):
Candel Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Lung Cancer Mesothelioma Breast Cancer Ovarian Cancer Biological: AdV-tk + valacyclovir Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Completion Date : February 2018

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Overall survival [ Time Frame: 10 years ]
    Follow up for survival for at least 10 years.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01997190

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Candel Therapeutics, Inc.
University of Pennsylvania
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Principal Investigator: Charu Aggarwal, MD University of Pennsylvania
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Responsible Party: Candel Therapeutics, Inc. Identifier: NCT01997190    
Other Study ID Numbers: MpeTK01
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Keywords provided by Candel Therapeutics, Inc.:
Gene therapy
Tumor vaccine
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antiviral Agents
Anti-Infective Agents