Study of Lung Chemotherapy in the Treatment of Advanced Lung Cancer and Metastatic Sarcoma

This is a phase I, open label, non-randomized single institution study to determine the maximum tolerated dose of cisplatin delivered selectively by isolated lung infusion (suffusion) to patients with unresectable lung cancer and metastatic sarcoma.

• Lung Cancer
• Sarcoma

Inclusion Criteria:

• Biopsy or cytologically proven unresectable stage IV, or unresectable stage IIIB non small cell lung cancer (including recurrent lung cancer) or metastatic sarcoma to the lung. This is defined as oligometastatic disease with > 80 % of measurable tumor volume in the target lung and no clinical evidence of CNS metastases. Oligometastatic disease is difficult to define but would have only 1-4 loci of disease established in 1-2 organ systems outside the affected lung. Generally, bulky metastatic disease causes performance impairment that would exceed 20% of tumor volume. 1)Unresectable Stage IV NSCLC,2) Unresectable Stage exclude the patient from being eligible because of the pulmonary and other requirements. Exceptions to these guidelines can occur, particularly in cases where sites of metastatic disease are equivocal or so minute that it would not IIIB NSCLC, 3)Resectable metastatic sarcoma to lung (Thoracoscopically resectable)
• ECOG status 0-1

Pulmonary Requirements:

• No oxygen needs
• Modified Borg Dyspnea scale<5
• Six minute walk Greater than or equal to 50% of the expected distance
• Ambulatory and resting oxygen saturation> 88%
• Predicted Post Operative(PPO) FEV1 greater than or equal to 50% predicted
• PPO DLCO greater than or equal to 50% predicted
• PPO Vital capacity greater than or equal to 50% predicted

Laboratory Requirements:

• Granulocytes > 1500ul
• Platelets > 100,000ul
• Must sign study specific consent prior to registration
• Tumor anatomy must be such that it will allow the isolated lung suffusion in judgment of PI.

Exclusion Criteria:

• Uncontrolled intercurrent disease
• Chemotherapy within 8 weeks
• Prior chemotherapy for proven metastatic disease
• Evidence of pulmonary toxicity from previous or ongoing chemotherapy

Insufficient organ reserve:

• Creatinine > 1.5 mg/dl
• Liver enzymes > 2 times upper normal
• Uncontrolled congestive heart failure
• Ejection fraction < 40%
• Myocardial infarction or angina within past 6 months
• Contraindications to anticoagulation
• Hydration intolerance (e.g.congestive heart failure)
• History of auditory impairment
• HIV+ on antiretroviral therapy (e.g.tinnitus, sensory-neural hearing loss)
• Pregnant or lactating
• Diffuse pulmonary fibrosis involving over 25% of the total lung parenchyma
• Previous radiation for thorax
• Metastatic sarcoma to lung that is not able to have tumors resected thoracoscopically will be excluded
• Prior lung removal in the affected lung (would have decreased lung volume)