Status:
COMPLETED
Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
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 tria...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00303901
Start Date
November 1 2005
End Date
July 1 2011
Last Update
July 22 2020
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379