Overview

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

Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
Prednisone
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