Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body

Wake Forest University (WFU)

Status

Withdrawn

Conditions

Advanced Malignant Mesothelioma

Stage IV Non-small Cell Lung Cancer

Recurrent Malignant Mesothelioma

Recurrent Small Cell Lung Cancer

Extensive Stage Small Cell Lung Cancer

Recurrent Non-small Cell Lung Cancer

Lung Metastases

Treatments

Procedure: cryotherapy

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT01325753

NCI-2011-00319 (Registry Identifier)

CCCWFU 62210 (Other Identifier)

IRB00015085

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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