Clinical trial NCT00890617: Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
Official title: A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Metastatic Cancer
Keywords: lung metastases
stage I non-small cell lung cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 patients with primary stage I non-small cell lung cancer or lung metastasis.

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.

Eligibility 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

Primary outcomes:
measure: The Number of Patients With a Response (Complete Response and Partial Response)
timeFrame: 3 weeks post-Percutaneous Cryotherapy (PTC)
Secondary outcomes:
measure: The Number of Patients With a Pathologic Response
timeFrame: 6 months post-Percutaneous Cryotherapy (PTC)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Frank A. Baciewicz, MD
role: PRINCIPAL_INVESTIGATOR
References: