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Intratumoral Cisplatin for Resectable NSCLC

Primary Purpose

Non-Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cis-diamminedichloroplatinum

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of VermontRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intratumoral Cisplatin Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of dose limiting toxicity

Adverse events as defined using the Common Terminology Criteria for Adverse Events

Secondary Outcome Measures

Major pathologic response

Evaluation of the tissue response to the drug

Blood biomarker panel

Includes serum cytokine analysis, mass cytometry for inflammatory cells, and complete blood count

Tissue biomarker panel

Includes evaluation of cellular constituents and sequencing of cells present in tissue

Full Information

NCT ID

NCT04809103

First Posted

March 8, 2021

Last Updated

May 20, 2022

Sponsor

University of Vermont

Collaborators

Johnson & Johnson

1. Study Identification

Unique Protocol Identification Number

NCT04809103

Brief Title

Intratumoral Cisplatin for Resectable NSCLC

Official Title

A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 8, 2021 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Vermont

Collaborators

Johnson & Johnson

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intratumoral Cisplatin Arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

cis-diamminedichloroplatinum

Other Intervention Name(s)

cisplatin

Intervention Description

Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC

Primary Outcome Measure Information:

Title

Rate of dose limiting toxicity

Description

Adverse events as defined using the Common Terminology Criteria for Adverse Events

Time Frame

Within 2 weeks of delivery

Secondary Outcome Measure Information:

Title

Major pathologic response

Description

Evaluation of the tissue response to the drug

Time Frame

Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery

Title

Blood biomarker panel

Description

Includes serum cytokine analysis, mass cytometry for inflammatory cells, and complete blood count

Time Frame

Assessed from blood drawn on day of bronchoscopy and day of surgical resection

Title

Tissue biomarker panel

Description

Includes evaluation of cellular constituents and sequencing of cells present in tissue

Time Frame

Assessed from tissue obtained on day of bronchoscopy and day of surgical resection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ardren Sara

Phone

8026563795

sara.ardren@uvmhealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

C. Matthew Kinsey, MD, MPH

Organizational Affiliation

University of Vermont

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Vermont

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05405

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara Ardren

Phone

802-656-3795

sara.ardren@uvmhealth.org

First Name & Middle Initial & Last Name & Degree

C. Matthew Kinsey

Phone

8026563525

Matt.Kinsey@uvmhealth.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intratumoral Cisplatin for Resectable NSCLC

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