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

NCT00303901 | Completed Results DMC

• 4 other identifiers: CDR0000462091P30CA022453WSU-C-2975WSU-0509002942
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer; Metastatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Local Failure Rates by CT Scan

  Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence

  at 3, 6, and 12 months

• Distant Failure Rate

  Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence

  at 3, 6, and 12 months

Secondary Outcomes (3)

• Rate of Complications and Adverse Reactions by Occurrences of Toxicities

  at 3, 6, and 12 months

• Correlate Procedural Parameters and Follow-up Imaging Parameters

  at 3, 6, and 12 months

• Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures

  12 months after the last patient was enrolled

Study Arms (1)

cryosurgery

EXPERIMENTAL

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

Interventions

cryosurgery PROCEDURE

cryosurgery

positron emission tomography PROCEDURE

cryosurgery

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Cryosurgery; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

There were no study limitations.

Results Point of Contact

• Title: Peter Littrup, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

littrupp@karmanos.org

313-576-8758

Study Officials

• Peter J. Littrup, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: November 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 22, 2020
• Results First Posted: February 23, 2015

Record last verified: 2020-07

Locations

US (1)