Trial record 1 of 1 for:    NCT00890617
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Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frank Baciewicz Jr., Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00890617
First received: April 29, 2009
Last updated: June 10, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Response rate (complete response and partial response) [ Time Frame: 3 weeks post-Percutaneous Cryotherapy (PTC) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: April 2013 (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:
  • Rayos
  • Sterapred

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890617

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Frank A. Baciewicz, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Frank Baciewicz Jr., Principal Investigator, 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: June 10, 2014
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 July 20, 2014