Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
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.
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This describes the study’s primary purpose.
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Checked against the public recordLast updated Jul 22, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Interventions being studied
- Procedure: cryosurgery; Procedure: positron emission tomography
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2020. Always confirm current availability with the study team.