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

NCT00890617 | Completed Phase 1 Results DMC

• 3 other identifiers: 2008-048P30CA022453WSU-2008-048
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Metastatic Cancer

Keywords

lung metastases; stage I non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With a Response (Complete Response and Partial Response)

  Treatment success was defined as \> 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p).

  3 weeks post-Percutaneous Cryotherapy (PTC)

Secondary Outcomes (1)

• The Number of Patients With a Pathologic Response

  6 months post-Percutaneous Cryotherapy (PTC)

Study Arms (1)

Prednisone & Cryotherapy

EXPERIMENTAL

Prednisone taken: 20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure

Procedure: Cryotherapy (PTC); Drug: Prednisone

Interventions

Cryotherapy (PTC) PROCEDURE

CT-guided PTC with the intent to eradicate the entire tumor(s).

Prednisone & Cryotherapy

Prednisone DRUG

Prednisone taken: 20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure

Also known as: Rayos, Sterapred

Prednisone & Cryotherapy

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 (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

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

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

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

Interventions

Cryotherapy; Prednisone

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)

Therapeutics; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Frank A. Baciewicz
• Organization: Barbara Ann Karmanos Cancer Institute

FBaciewi@dmc.org; baciewic@karmanos.org

(313) 993-0580

Study Officials

• Frank A. Baciewicz, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: April 29, 2009
• First Posted: April 30, 2009
• Study Start: March 1, 2009
• Primary Completion: July 27, 2019
• Study Completion: May 1, 2021
• Last Updated: November 1, 2022
• Results First Posted: July 29, 2020

Record last verified: 2022-10

Locations

US (1)