Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis

October 29, 2022 updated by: Frank Baciewicz Jr., Barbara Ann Karmanos Cancer Institute

A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer

RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery may kill more tumor cells.

PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with primary stage I non-small cell lung cancer or lung metastasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the histologic result of treating patients with primary stage I non-small cell lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC).

Secondary

  • Provide a qualitative assessment of the histology from the ablation and tumor margins, comparing histologic observations with imaging-enhancement patterns by CT or PET scan before and after PTC.

OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours. Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of lobectomy of the primary lung cancer or wedge resection with adequate margin for the metastatic lesion, and mediastinal lymph node dissection.

Tissue samples from ablation and tumor margins are collected during thoracotomy and compared with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC.

After completion of study therapy, patients are followed periodically for 6 months.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed (by percutaneous transthoracic needle biopsy or transbronchial biopsy) diagnosis of 1 the following:

    • Non-small cell lung carcinoma

      • Stage I disease
      • Primary disease
      • No primary lung metastatic disease, satellite lesions of the chest, mediastinal lymph nodes > 1.5 cm, hepatic or adrenal masses by the PET scan or the CT scan

    • Metastatic cancer to the lung

      • Must have a definitive cancer diagnosis with the primary tumor under local control and no metastatic disease other than to the lung
      • Solitary or multiple (≤ 3) peripheral lung lesions
      • No chemotherapy since the new metastatic lesion appeared
  • Measurable disease, defined as 1 lesion unidimensionally measured ≤ 3.0 cm by conventional CT scan techniques
  • Must be registered with the Clinical Trials office at the Karmanos Cancer Center/Wayne State University
  • Must be a candidate for a thoracotomy
  • No evidence of cerebral disease or metastatic disease of the brain

PATIENT CHARACTERISTICS:

  • Neutrophil count > 1,500/mm^3
  • Platelet count > 75,000/mm^3
  • PT and PTT normal
  • FEV_1 > 1.0 L/sec
  • Diffusing capacity ≥ 30%
  • Not pregnant or nursing

  • No other uncontrolled or concurrent illnesses including, but not limited to, any of the following conditions:

    • Active infection
    • Heart failure
    • Unstable angina
    • Cardiac dysrhythmia
    • Psychiatric illness or a social situation that would limit compliance with the study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiation therapy or chemotherapy for these particular tumors
  • No concurrent aspirin or other platelet-inhibiting drugs (e.g., coumadin or heparin)
  • No other concurrent experimental studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisone & Cryotherapy

Prednisone taken:

20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Procedure: Cryotherapy (PTC)
CT-guided PTC with the intent to eradicate the entire tumor(s).
Drug: Prednisone

Prednisone taken:

20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure

Other Names:
  • Rayos
  • Sterapred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Patients With a Response (Complete Response and Partial Response)
Time Frame: 3 weeks post-Percutaneous Cryotherapy (PTC)
Treatment success was defined as > 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p).
3 weeks post-Percutaneous Cryotherapy (PTC)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Patients With a Pathologic Response
Time Frame: 6 months post-Percutaneous Cryotherapy (PTC)
Histology samples from anterior, posterior, superior, inferior, medial and lateral areas of the resected tumor will be compared to enhancement zones of the ablation margin for any residual cancer.
6 months post-Percutaneous Cryotherapy (PTC)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Frank A. Baciewicz, MD, Barbara Ann Karmanos Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 27, 2019

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

April 29, 2009

First Submitted That Met QC Criteria

April 29, 2009

First Posted (Estimate)

April 30, 2009

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 29, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-048
  • P30CA022453 (U.S. NIH Grant/Contract)
  • WSU-2008-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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