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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCryotherapy (PTC) and Prednisone

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 1, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Barbara Ann Karmanos Cancer Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Barbara Ann Karmanos Cancer Institute
Interventions being studied: Procedure: Cryotherapy (PTC); Drug: Prednisone

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Metastatic or stage IV→

Treatment approach

Surgery→

Study topics

Before surgery (neoadjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 1, 2022. Always confirm current availability with the study team.

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