Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis

Lung Cancer Clinical Trial

Official title:

A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890617
• Other study ID #: 2008-048
• Secondary ID: P30CA022453WSU-2
• Status: Completed
• Phase: Phase 1
• Start date: March 2009
• Est. completion date: May 2021

Study information

• Verified date: October 2022
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery may kill more tumor cells.

PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with primary stage I non-small cell lung cancer or lung metastasis.

Description:

OBJECTIVES:

Primary

• Evaluate the histologic result of treating patients with primary stage I non-small cell lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC).

Secondary

• Provide a qualitative assessment of the histology from the ablation and tumor margins, comparing histologic observations with imaging-enhancement patterns by CT or PET scan before and after PTC.

OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours. Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of lobectomy of the primary lung cancer or wedge resection with adequate margin for the metastatic lesion, and mediastinal lymph node dissection.

Tissue samples from ablation and tumor margins are collected during thoracotomy and compared with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC.

After completion of study therapy, patients are followed periodically for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2021
• Est. primary completion date: July 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed (by percutaneous transthoracic needle biopsy or transbronchial biopsy) diagnosis of 1 the following:

• Non-small cell lung carcinoma

• Stage I disease

• Primary disease

• No primary lung metastatic disease, satellite lesions of the chest, mediastinal lymph nodes > 1.5 cm, hepatic or adrenal masses by the PET scan or the CT scan

• Metastatic cancer to the lung

• Must have a definitive cancer diagnosis with the primary tumor under local control and no metastatic disease other than to the lung

• Solitary or multiple (= 3) peripheral lung lesions

• No chemotherapy since the new metastatic lesion appeared

• Measurable disease, defined as 1 lesion unidimensionally measured = 3.0 cm by conventional CT scan techniques

• Must be registered with the Clinical Trials office at the Karmanos Cancer Center/Wayne State University

• Must be a candidate for a thoracotomy

• No evidence of cerebral disease or metastatic disease of the brain

PATIENT CHARACTERISTICS:

• Neutrophil count > 1,500/mm^3

• Platelet count > 75,000/mm^3

• PT and PTT normal

• FEV_1 > 1.0 L/sec

• Diffusing capacity = 30%

• Not pregnant or nursing

• No other uncontrolled or concurrent illnesses including, but not limited to, any of the following conditions:

• Active infection

• Heart failure

• Unstable angina

• Cardiac dysrhythmia

• Psychiatric illness or a social situation that would limit compliance with the study requirements

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior radiation therapy or chemotherapy for these particular tumors

• No concurrent aspirin or other platelet-inhibiting drugs (e.g., coumadin or heparin)

• No other concurrent experimental studies

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer

Intervention

Procedure:
• Cryotherapy (PTC)
CT-guided PTC with the intent to eradicate the entire tumor(s).

Drug:
• Prednisone
Prednisone taken: 20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Patients With a Response (Complete Response and Partial Response)	Treatment success was defined as > 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p).	3 weeks post-Percutaneous Cryotherapy (PTC)
Secondary	The Number of Patients With a Pathologic Response	Histology samples from anterior, posterior, superior, inferior, medial and lateral areas of the resected tumor will be compared to enhancement zones of the ablation margin for any residual cancer.	6 months post-Percutaneous Cryotherapy (PTC)

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database