Phase 1
N=9
Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
Lung Cancer · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00890617 ↗Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Jul 2020
Primary outcome: Primary: The Number of Patients With a Response (Complete Response and Partial Response) — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cryotherapy (PTC) (Procedure); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients With a Response (Complete Response and Partial Response) |
8 | — |
| SECONDARY The Number of Patients With a Pathologic Response |
1; 2; 6 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00890617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.