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Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer

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.
 
ClinicalTrials.gov Identifier: NCT03131037
Recruitment Status : Unknown
Verified January 2021 by Candel Therapeutics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Candel Therapeutics, Inc.

Study Description
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Brief Summary:
This is a phase I study of Gene Mediated Cytotoxic Immunotherapy (GMCI) in patients with non-small cell lung cancer (NSCLC). The primary clinical end-point of the study is to evaluate the safety of GMCI when combined with standard surgery for NSCLC. The primary scientific objective is to determine the immunologic changes induced by GMCI.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: AdV-tk (aglatimagene besadenovec) + valacyclovir Phase 1

Detailed Description:

The purpose of this open-label, dose escalation clinical trial is to investigate the safety of GMCI prior to surgery in patients with NSCLC. GMCI involves the use of aglatimagene besadenovec (AdV-tk) injected into the tumor followed by oral valacyclovir prodrug to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. GMCI has been well tolerated in previous trials in multiple tumor types with clinical, pathologic and immune responses.

AdV-tk will be injected intratumorally on day 0 during a standard of care staging procedure. The prodrug, valacyclovir, will be administered orally at a fixed dose for 14 days following the AdV-tk injection. Then standard of care surgical resection will be performed about 3 weeks after the AdV-tk injection. Chemotherapy and/or radiation may begin 6-8 weeks after resection surgery. Choice of chemotherapy depends on the treating oncologist.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Intratumoral Gene Mediated Cytotoxic Immunotherapy (GMCI) For Resectable Non-Small Cell Lung Cancer
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Arm
AdV-tk (aglatimagene besadenovec) + valacyclovir
 Biological: AdV-tk (aglatimagene besadenovec) + valacyclovir
AdV-tk will be administered intratumorally followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration.


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: 6 weeks ]
    Safety based on standard laboratory and clinical adverse event monitoring.


Secondary Outcome Measures :
  1. Immunologic changes [ Time Frame: 12 months ]
    The effect of GMCI on the histology and immune profile of the resected tumor. Systemic and intratumoral cytokine responses will also be assessed.

  2. Progression free survival (PFS) [ Time Frame: 5 years ]
    The PFS curves will be estimated using the Kaplan-Meier method.

  3. Overall survival (OS) [ Time Frame: 5 years ]
    The OS curves will be estimated using the Kaplan-Meier method.


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

Inclusion Criteria:

  • Pathologically documented non-small cell carcinoma (cytology or histology) that is accessible via standard-of-care staging procedures: (1) EBUS or (2) surgical approaches (eg mediastinoscopy, mediastinotomy or VATS).
  • Resectable with negative lymph nodes based on imaging with histologic confirmation at time of the staging procedure prior to AdV-tk injection
  • The tumor must be 4cm or greater in diameter based on imaging
  • ECOG Performance status of 0 or 1.
  • Granulocyte count (ANC) ≥ 1,000/mm3
  • Peripheral lymphocyte count ≥ 500/mm3
  • Hemoglobin ≥ 9 g/dl
  • Platelets ≥ 100,000/mm3
  • Total bilirubin ≤ 1.5 x upper limit of normal
  • SGOT (AST) ≤ 3x upper limit of normal
  • Serum creatinine < 2mg/dl
  • Calculated creatinine clearance > 30ml/min
  • Patients must give study specific informed consent prior to enrollment

Exclusion Criteria:

  • Radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 4 weeks prior to infusion of the vector.
  • Known immunodeficiency such as HIV infection
  • Active liver disease, including known cirrhosis or active hepatitis
  • Use of systemic corticosteroids (>10 mg prednisone per day or equivalent) or other systemic immunosuppressive drugs
  • Patient is pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy. Subjects must use acceptable means of birth control until 30 days after the vector injection.
  • Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end-stage liver or renal disease. COPD will be considered significant if disease limits activities of daily living, results in the inability to walk up 1 flight of stair, or requires home oxygen.
  • Presence of known untreated brain metastases.
  • Prior bone marrow transplants (including stem cells) except autologous stem cell transplant without immunosuppression is NOT considered an exclusion.
  • Known sensitivity or allergic reactions to valacyclovir
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03131037


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Candel Therapeutics, Inc.
University of Pennsylvania
More Information
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Responsible Party: Candel Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03131037    
Other Study ID Numbers: LuTK01
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Candel Therapeutics, Inc.:
immunotherapy
immuno-oncology
tumor vaccine
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Valacyclovir
Antiviral Agents
Anti-Infective Agents