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

• Sponsor: Barbara Ann Karmanos Cancer Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00890617
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 165
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Metastatic Cancer	Procedure: Cryotherapy (PTC); Drug: Prednisone	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jul 27, 2019
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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

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; Other Names: Rayos Sterapred

Outcome Measures

Primary Outcome Measures

1. The Number of Patients With a Response (Complete Response and Partial Response) [3 weeks post-Percutaneous Cryotherapy (PTC)]

   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).

Secondary Outcome Measures

1. The Number of Patients With a Pathologic Response [6 months post-Percutaneous Cryotherapy (PTC)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379

Sponsors and Collaborators

• Barbara Ann Karmanos Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Frank A. Baciewicz, MD, Barbara Ann Karmanos Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 15, 2012

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Frank Baciewicz Jr., Principal Investigator, Barbara Ann Karmanos Cancer Institute
• ClinicalTrials.gov Identifier: NCT00890617
• Other Study ID Numbers: CDR0000640304; P30CA022453; WSU-2008-048
• First Posted: Apr 30, 2009
• Last Update Posted: Nov 3, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Frank Baciewicz Jr., Principal Investigator, Barbara Ann Karmanos Cancer Institute: lung metastases; stage I non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Prednisone

Study Results

Participant Flow

Arm/Group Title	Prednisone & Cryotherapy
Arm/Group Description	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 Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s). 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
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Prednisone & Cryotherapy
Arm/Group Description	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 Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s). 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
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 44.4%
>=65 years	5 55.6%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	65.78
Sex: Female, Male (Count of Participants)
Female	2 22.2%
Male	7 77.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 55.6%
White	4 44.4%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	The Number of Patients With a Response (Complete Response and Partial Response)
Description	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).
Time Frame	3 weeks post-Percutaneous Cryotherapy (PTC)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone & Cryotherapy
Arm/Group Description	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 Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s). 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
Measure Participants	9
Count of Participants [Participants]	8 88.9%

2. Secondary Outcome

Title	The Number of Patients With a Pathologic Response
Description	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.
Time Frame	6 months post-Percutaneous Cryotherapy (PTC)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone & Cryotherapy
Arm/Group Description	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 Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s). 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
Measure Participants	9
macroscopic residual viable tumor	1 11.1%
microscopic foci of viable tumor	2 22.2%
no microscopic viable tumor	6 66.7%

Adverse Events

Time Frame	over the first 6 months of study
Adverse Event Reporting Description	CTCAE criteria
Arm/Group Title	Prednisone & Cryotherapy
Arm/Group Description	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 Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s). 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
All Cause Mortality
	Prednisone & Cryotherapy
	Affected / at Risk (%)	# Events
Total	2/9 (22.2%)
Serious Adverse Events
	Prednisone & Cryotherapy
	Affected / at Risk (%)	# Events
Total	2/9 (22.2%)
Cardiac disorders
atrial fibrillation	1/9 (11.1%)	1
Respiratory, thoracic and mediastinal disorders
aspergillosis	1/9 (11.1%)	1
Other (Not Including Serious) Adverse Events
	Prednisone & Cryotherapy
	Affected / at Risk (%)	# Events
Total	9/9 (100%)
Cardiac disorders
atrial fibrillation	2/9 (22.2%)	2
Infections and infestations
pneumonia	2/9 (22.2%)	2
Injury, poisoning and procedural complications
vocal cord dysfunction	2/9 (22.2%)	2
Respiratory, thoracic and mediastinal disorders
atelectasis	3/9 (33.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.