Intratumoral Cisplatin for Resectable NSCLC

NCT ID: NCT04809103

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2024-09-01

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cis-diamminedichloroplatinum

Intervention Type: DRUG

Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC

Interventions

cis-diamminedichloroplatinum

Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC

Intervention Type: DRUG

Other Intervention Names

cisplatin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

C. Matthew Kinsey MD, MPH

Director, Interventional Pulmonary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C. Matthew Kinsey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ardren Sara

Role: CONTACT

sara.ardren@uvmhealth.org

8026563795

Facility Contacts

Sara Ardren

Role: primary

sara.ardren@uvmhealth.org

802-656-3795

C. Matthew Kinsey

Role: backup

Matt.Kinsey@uvmhealth.org

8026563525

Other Identifiers

00001101

Identifier Type: -

Identifier Source: org_study_id