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

NCT01325753 | Withdrawn DMC

• 3 other identifiers: IRB00015085NCI-2011-00319CCCWFU 62210
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Safety of interventional cryoablation to the lung

  Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

  6 months

Secondary Outcomes (4)

• Local control measured by imaging

  At 1 year

• Changes in Physical function and quality of life

  approximately 60 months

• Changes in pulmonary function

  At 3 months

• Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial

  approximately 60 months

Study Arms (1)

Treatment (cryoablation)

EXPERIMENTAL

Patients undergo CT-guided CA.

Procedure: cryotherapy; Procedure: quality-of-life assessment

Interventions

cryotherapy PROCEDURE

Undergo CT-guided CA

Treatment (cryoablation)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (cryoablation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Mesothelioma, Malignant; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• James Urbanic

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 30, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-07