Advanced Malignant Mesothelioma, Extensive Stage Small Cell Lung Cancer, Lung Metastases, Recurrent Malignant Mesothelioma, Recurrent Non-small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Conditions
Brief summary
This pilot clinical trial studies the side effects of cryotherapy (cryoablation \[CA\]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.
Detailed description
PRIMARY OBJECTIVES: I. Assess the initial safety of the CA for lung tumors less than or equal to 3.5 cm in size including acute toxicity (30 days). SECONDARY OBJECTIVES: I. Estimate local control. II. To assess physical function for this cohort of patients. III. To evaluate the impact of treatment on generic and disease-specific quality of life. IV. To obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial. V. Evaluate changes in pulmonary function at 3 months. OUTLINE: Patients undergo computed tomography (CT)-guided CA After completion of study treatment, patients are followed up at 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months.
Interventions
PROCEDUREcryotherapy
Undergo CT-guided CA
PROCEDUREquality-of-life assessment
Ancillary studies
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura. * Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease * The target lesion is determined (by CT or magnetic resonance imaging \[MRI\] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures * Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side) * Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy * If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week * The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be =\< 3.5 cm in greatest dimension * All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient * Performance Status 0-2 (Eastern Cooperative Oncology Group \[ECOG\]); Karnofsky Performance Scale \>= 60 * Life expectancy \> 3 months * Clinically suitable for cryoablation procedure as determined by the treating physician * Platelet count \> 50,000/mm\^3 within 60 days prior to study registration * International normalized ratio (INR) \< 1.5 within 60 days prior to study registration * Absolute neutrophil count (ANC) \< 1000 within 21 days prior to study registration * A signed study specific consent form is required
Exclusion criteria
* Primary lung cancer * Unable to lie flat or has respiratory distress at rest * Uncontrolled coagulopathy or bleeding disorders * Evidence of active systemic, pulmonary, or pericardial infection * Pregnant, nursing or wishes to become pregnant during the study * Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up * Currently participating in other experimental studies that could affect the primary endpoint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of interventional cryoablation to the lung | 6 months | Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control measured by imaging | At 1 year | Measure definitions: * Complete Response(tumor disappearance or less than 25% of original size) * Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors) * stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors) * Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors) * Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area) |
| Changes in Physical function and quality of life | approximately 60 months | Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery |
| Changes in pulmonary function | At 3 months | Measure by pulmonary function test |
| Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial | approximately 60 months | — |
Outcome results
None listed