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Intratumoral Cisplatin for Resectable NSCLC

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ClinicalTrials.gov Identifier: NCT04809103
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
C. Matthew Kinsey MD, MPH, University of Vermont

Brief Summary:

PRIMARY OBJECTIVE:

To identify the maximum tolerated dose (MTD) of intratumoral cisplatin, delivered during a single bronchoscopy with cone-beam CT confirmation, in a dose escalation protocol

DESIGN: 3+3 dose escalation.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: cis-diamminedichloroplatinum Phase 1

Detailed Description:

Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the United States. Even for early stage disease, the rate of recurrence following surgical resection is as high as 50%. Although neoadjuvant therapy, administered before surgery, for early stage lung cancer is associated with a survival benefit, it is rarely used due to the systemic toxicity of intravenous (IV) cytotoxic chemotherapy. IV immunotherapies are also being evaluated in combination with systemic therapies in the neoadjuvant setting. However, only a minority of patients respond to immunotherapy. One of the most common reasons for failure of immunotherapy is lack of presentation of tumor antigens to the immune system, a problem that may be potentially addressed with cytotoxic agents.

Over the last several years, case series have demonstrated the feasibility and safety of delivering cisplatin directly into lung tumors. Given the current knowledge of safety and tolerability of intratumoral cisplatin, coupled with the potential to achieve immune priming that may help address systemic micrometastases, the investigators postulate that intratumoral cisplatin will be well-tolerated, and potentially effective, neoadjuvant therapy for patients with early stage, resectable, non-small cell lung cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: Intratumoral Cisplatin Arm
Single arm approach. There is no comparator or placebo group. Cisplatin will be administered directly into a non-small cell lung cancer, following imaging verification and pathologic diagnosis, during a single bronchoscopic procedure.
Drug: cis-diamminedichloroplatinum
Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
Other Name: cisplatin




Primary Outcome Measures :
  1. Rate of dose limiting toxicity [ Time Frame: Within 2 weeks of delivery ]
    Adverse events as defined using the Common Terminology Criteria for Adverse Events


Secondary Outcome Measures :
  1. Major pathologic response [ Time Frame: Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery ]
    Evaluation of the tissue response to the drug

  2. Blood biomarker panel [ Time Frame: Assessed from blood drawn on day of bronchoscopy and day of surgical resection ]
    Includes serum cytokine analysis, mass cytometry for inflammatory cells, and complete blood count

  3. Tissue biomarker panel [ Time Frame: Assessed from tissue obtained on day of bronchoscopy and day of surgical resection ]
    Includes evaluation of cellular constituents and sequencing of cells present in tissue



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
Criteria

Inclusion Criteria:

  • Age ≥18 years.
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Patients must have adequate organ and marrow function as defined below:

    • Leukocytes ≥3,000/microliter
    • Platelets ≥100,000/microliter
    • Total bilirubin ≤ institutional upper limit of normal (ULN)
    • Aspartate aminotransferase /Alanine aminotransferase ≤3 × institutional upper limit of normal
    • Creatinine ≤ institutional ULN
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Have known or suspected clinical stage I-IIb NSCLC after computed tomography (CT) and/or positron emission tomography at time of enrollment
  • Presence of a target lesion with a minimum volume of 1.0 cm3, (approximately1.2 cm in diameter) and ≤ 5.0 cm in diameter
  • Agreement from a cardiothoracic surgeon, following review of past medical history, medications, pulmonary function testing, and CT scan that patient is likely to be a surgical candidate and that, after considering known possible adverse events, delivery of intratumoral cisplatin is unlikely to adversely affect surgical feasibility
  • Rapid on-site cytopathologic examination (ROSE) performed during the procedure returns likely NSCLC (per the determination of a trained, attending, cytopathologist). No research procedures will be performed if ROSE is non-diagnostic
  • A CT scan of the chest (with or without contrast) within 1 month of the screening visit
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Use of an investigational agent within 30 days of the screening visit
  • IV chemotherapy within the 30 days of the screening visit
  • Pregnancy/lactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by University of Vermont Medical Center Policy
  • History of prior radiation to the study lesion
  • History of allergic reaction to cisplatin or its derivatives
  • Patients with uncontrolled intercurrent illness
  • Physician determination that patient would not be appropriate for study

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): NCT04809103


Contacts
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Contact: Ardren Sara 8026563795 sara.ardren@uvmhealth.org

Locations
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United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Sara Ardren    802-656-3795    sara.ardren@uvmhealth.org   
Contact: C. Matthew Kinsey    8026563525    Matt.Kinsey@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
Johnson & Johnson
Investigators
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Principal Investigator: C. Matthew Kinsey, MD, MPH University of Vermont
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Responsible Party: C. Matthew Kinsey MD, MPH, Director, Interventional Pulmonary, University of Vermont
ClinicalTrials.gov Identifier: NCT04809103    
Other Study ID Numbers: 00001101
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Antineoplastic Agents