Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer (NCT00514215) | Clinical Trial Compass
CompletedPhase 2
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
United States8 participantsStarted 2006-01
Plain-language summary
RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving an injection of GM-CSF before cryotherapy and inhaling GM-CSF after cryotherapy may interfere with the growth of tumor cells and shrink the tumor. Giving cryotherapy together with GM-CSF may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cryotherapy together with GM-CSF works in treating patients with lung metastases or primary lung cancer.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Primary non-small cell lung cancer (NSCLC)
* Any stage nonoperative NSCLC or patient refuses surgery
* Any cancer with pulmonary metastatic disease (including renal cell cancer)
* Stage IV disease (any T, any N, M1)
* Must have 1-10 pulmonary or mediastinal masses meeting the following criteria:
* At least 1 mass is appropriate for 2 sessions of core biopsy and cryotherapy with relatively easy access/low risk in nonoperative patients (or those refusing surgery)
* The two dominant masses are defined as either the largest and/or those that may cause imminent morbidity from continued local progression, thereby potentially benefiting from thoracic cryotherapy alone
* Optimal tumor size \> 1.0 cm
* Dominant masses up to 6 cm in diameter may be considered if thorough cryotherapy coverage can be anticipated with minimal additional treatment morbidity
* Measurable disease, defined as tridimensional measurements of up to 6 different pulmonary or mediastinal masses ≥ 0.5 cm by CT scan
* No active pleural effusion that could be related to respiratory infection or requires further work-up
* No untreated and/or unstable brain metastases
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Life expectancy ≥ 12 weeks
* Granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 50,000/mm³
* INR \< 1.5 (i.e., normal PT/PTT)
* Hemoglobin ≥ 8.0 g/dL
* Bilirubin ≤ 2 times upper…
What they're measuring
1
Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry