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Phase 1 N=9 Treatment

Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis

Lung Cancer · Metastatic Cancer

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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