Status:
COMPLETED
Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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 ...
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). Second...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00890617
Start Date
March 1 2009
End Date
May 1 2021
Last Update
November 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379