Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
Lung Cancer, Malignant Mesothelioma, Metastatic Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, advanced malignant mesothelioma, recurrent malignant mesothelioma, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, pulmonary carcinoid tumor, lung metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery Clinical evidence of primary lung or tracheal cancer OR Metastatic cancer to the lung Extrathoracic metastases eligible if following criteria are met: Sites are stable Pulmonary sites are primary life-threatening sites Evidence that study treatment may benefit the patient Measurable or evaluable disease No germ cell tumor, leukemia, or lymphoma involving the lungs that is treatable with systemic agents No complete atelectasis due to high-grade airway obstruction PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.0 mg/dL AST and ALT less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 40% by MUGA scan or echocardiogram No unstable angina, congestive heart failure, or symptomatic arrhythmias Pulmonary: DLCO at least 50% predicted FVC and FEV1 at least 50% predicted Resting oxygen saturation at least 90% Exercise oxygen saturation at least 85% Oxygen consumption greater than 50% predicted No prior radiation pneumonitis No asthma No radiation-induced pulmonary damage Other: No hypersensitivity to doxorubicin Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study HIV negative No congenital problems (e.g., cleft palate) or other anomalies that prevent tight fit of a mouthseal PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No prior trastuzumab (Herceptin) Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Prior doxorubicin allowed if LVEF at least 40% by MUGA scan or echocardiogram No prior mitomycin, bleomycin, or nitrosoureas No other concurrent systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered At least 12 months since prior radiotherapy to chest No prior radiotherapy to more than 20% of total lung volume Prior chest wall or primary breast radiotherapy allowed Prior radioactive iodine allowed No concurrent thoracic radiotherapy Surgery: See Disease Characteristics No prior total pneumonectomy Other: No other concurrent experimental drug
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support