Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Littrup, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00303901
First received: March 15, 2006
Last updated: November 18, 2013
Last verified: April 2013
  Purpose

RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery.

PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.


Condition Intervention
Lung Cancer
Metastatic Cancer
Procedure: cryosurgery
Procedure: positron emission tomography

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Local and distant failure rates by CT scan [ Time Frame: at 3, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complications and adverse reactions by occurrences of toxicities [ Time Frame: at 3, 6, and 12 months ] [ Designated as safety issue: Yes ]
  • Correlate procedural parameters and follow-up imaging parameters [ Time Frame: at 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Point and exact confidence interval estimates of patients who undergo multiple cryotherapy procedures [ Time Frame: 12 months after the last patient was enrolled ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: November 2005
Estimated Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cryosurgery
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
Procedure: cryosurgery Procedure: positron emission tomography

Detailed Description:

OBJECTIVES:

  • Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases.
  • Estimate rates of PTC complications and adverse reactions.
  • Determine the correlations between procedural parameters and follow-up imaging parameters, with the latter being used as surrogates of local and/or distant treatment failure.

OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume.

Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable.

After completion of study treatment, patients are followed at 1, 3, 6 and 12 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  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 malignant pulmonary neoplasm
  • New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed

    • Imaging findings compatible with localized treatment failure after prior cryotherapy allowed
  • Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy
  • Metastatic disease must meet all of the following criteria:

    • Primary tumors have been resected or have been deemed controlled by other therapies
    • No other widespread metastases evident (e.g., multiple hepatic or brain metastases)
  • Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach
  • No more than 5 targeted masses for study therapy

    • Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter
  • Unresectable disease by surgical consultation OR patient refused surgical options
  • Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors

    • PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2
  • FEV_1 > 30% of predicted
  • DLCO > 40% of predicted
  • Platelet count ≥ 70,000/mm^3
  • INR < 1.5
  • No uncontrolled coagulopathy or bleeding diathesis
  • Not pregnant or nursing
  • Negative pregnancy test
  • No serious medical illness, including any of the following:

    • Uncontrolled congestive heart failure
    • Uncontrolled angina
    • Myocardial infarction
    • Cerebrovascular event within 6 months prior to study entry
  • No medical contraindication or potential problem that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • At least 7 days since prior aspirin and aspirin-like medications
  • At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds
  • No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate)
  • No concurrent participation in other 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: NCT00303901

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Peter J. Littrup, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Peter Littrup, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00303901     History of Changes
Other Study ID Numbers: CDR0000462091, P30CA022453, WSU-C-2975, WSU-0509002942
Study First Received: March 15, 2006
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
lung metastases
recurrent non-small cell lung cancer
recurrent small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer
pulmonary carcinoid tumor

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014