This phase I trial studies the side effects and best dose of cisplatin in treating patients with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they started to the lung (metastasis). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cisplatin directly into the arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose and dose-limiting toxicities of cisplatin when delivered selectively by isolated lung suffusion to patients with any biopsy or cytologically proven resectable or unresectable primary or secondary malignancy in the lung. SECONDARY OBJECTIVES: I. To assess lung tissue levels of cisplatin after isolated lung suffusion as a function of the dose delivered. II. To evaluate systemic and pulmonary artery concentrations of cisplatin during isolated lung suffusion. OUTLINE: This is a dose-escalation study. Patients receive cisplatin intra-arterially via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks if indicated for patients with sarcoma undergoing surgery after cisplatin), patients receive standard chemotherapy regimen. After completion of study treatment, patients are followed up for at least 90 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given intra-arterially via isolated lung suffusion
Correlative studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Acute toxicity assessed using CTCAE version 4.0
Time frame: Within 7 days from lung infusion
Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT
DLT is defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A grade 3 or above adverse event shall be considered a DLT in this study if attributed to the isolated lung suffusion cisplatin dose.
Time frame: Within 30 days of the procedure
Reversibility of all toxicities from this approach.
Time frame: Up to 90 days from the start of lung infusion therapy
Lung, systemic, and pulmonary artery concentrations of cisplatin
Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.
Time frame: Before pulmonary artery release, at 15 minutes, and 1 hour
Pulmonary function test with diffusion capacity
Will be summarized with respect to the percentage of cisplatin given directly to the lung. Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.
Time frame: Up to 30 days post-treatment
Split lung function test
Will be summarized with respect to the percentage of cisplatin given directly to the lung. Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.
Time frame: Up to 30 days post-treatment
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