Clinical trial NCT01325753: Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body
Official title: A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of interventional cryoablation to the lung
timeFrame: 6 months
Secondary outcomes:
measure: Local control measured by imaging
timeFrame: At 1 year
measure: Changes in Physical function and quality of life
timeFrame: approximately 60 months
measure: Changes in pulmonary function
timeFrame: At 3 months
measure: Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial
timeFrame: approximately 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: James Urbanic
role: PRINCIPAL_INVESTIGATOR
References: