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

NCT ID: NCT00890617

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2021-05-31

Brief 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.

Detailed 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.

Conditions

Lung Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prednisone & Cryotherapy

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

Group Type: EXPERIMENTAL

Cryotherapy (PTC)

Intervention Type: PROCEDURE

CT-guided PTC with the intent to eradicate the entire tumor(s).

Prednisone

Intervention Type: DRUG

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

Interventions

Cryotherapy (PTC)

CT-guided PTC with the intent to eradicate the entire tumor(s).

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

Rayos; Sterapred

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Frank Baciewicz Jr.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank A. Baciewicz, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://cancer.gov/clinicaltrials

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

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-2008-048

Identifier Type: -

Identifier Source: secondary_id

2008-048

Identifier Type: -

Identifier Source: org_study_id