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

Primary Purpose

Lung Cancer, Metastatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cryotherapy (PTC)

Prednisone

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung metastases, stage I non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prednisone & Cryotherapy

Arm 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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00890617

First Posted

April 29, 2009

Last Updated

October 29, 2022

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00890617

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

July 27, 2019 (Actual)

Study Completion Date

May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Metastatic Cancer

Keywords

lung metastases, stage I non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prednisone & Cryotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Cryotherapy (PTC)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

Rayos, Sterapred

Intervention Description

Primary Outcome Measure Information:

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)

Secondary Outcome Measure Information:

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank A. Baciewicz, MD

Organizational Affiliation

Barbara Ann Karmanos Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barbara Ann Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201-1379

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cancer.gov/clinicaltrials

Description

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

Learn more about this trial

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

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