Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer Metastatic Cancer |
Procedure: Cryotherapy (PTC) Drug: Prednisone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Response rate (complete response and partial response) [ Time Frame: 3 weeks post-Percutaneous Cryotherapy (PTC) ] [ Designated as safety issue: No ]
- Pathologic response [ Time Frame: 6 months post-Percutaneous Cryotherapy (PTC) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2009 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Principal Investigator: | Frank A. Baciewicz, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00890617 History of Changes |
| Other Study ID Numbers: | CDR0000640304, P30CA022453, WSU-2008-048 |
| Study First Received: | April 29, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
lung metastases stage I non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Neoplastic Processes Pathologic Processes Prednisone Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013