Overview

This trial is active, not recruiting.

Conditions lung cancer, metastatic cancer
Treatments cryotherapy (ptc), prednisone
Phase phase 1
Sponsor Barbara Ann Karmanos Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date March 2009
End date April 2013
Trial size 10 participants
Trial identifier NCT00890617, CDR0000640304, P30CA022453, WSU-2008-048

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Rayos
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

Primary Outcomes

Measure
Response rate (complete response and partial response)
time frame: 3 weeks post-Percutaneous Cryotherapy (PTC)

Secondary Outcomes

Measure
Pathologic response
time frame: 6 months post-Percutaneous Cryotherapy (PTC)

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer
Principal investigator Frank A. Baciewicz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute.