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This study examined inhaled sargramostim together with surgery in patients whose osteosarcoma (a bone cancer) had spread to the lungs for the first time. Patients aged 39 and under with histologically confirmed osteosarcoma and surgically removable lung nodules could take part. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * Histologically confirmed osteosarcoma at primary diagnosis * Lesions detected in at least 1 lung that are consistent with metastatic disease and approachable with thoracotomy * No prior recurrence of osteosarcoma * No other sites of metastases * Resectable pulmonary nodule(s), defined as nodule(s) that are removable without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels) * Prior thoracotomy allowed in patients with imaging consistent with metastatic involvement in both lungs provided the lung on which the thoracotomy was performed is disease-free * No pleural effusion or pleural based nodules PATIENT CHARACTERISTICS: Age * 39 and under Performance status * Karnofsky 50-100% (patients over 16 years of age) * Lansky 50-100% (patients 16 years of age and under) Life expectancy * At least 8 weeks Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Pulmonary * No evidence of dyspnea at rest * No exercise intolerance * Pulse oximetry at least 94% * Baseline Forced expiratory volume in 1 second (FEV\_1) at least 80% of predicted * No history of asthma * No history of reactive airway disease * No history of bronchospasm Other * Willing and able to perform inhalation therapy * No medical contraindication to surgical excision * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent immunotherapy * No other concurrent immunomodulating agents Chemotherapy * No concurrent anticancer chemotherapy Endocrine therapy * No concurrent steroids by any route Radiotherapy * Not specified Surgery * See Disease Characteristics * No concurrent thoracoscopy or video-assisted thoracic surgery Other * No more than 1 prior treatment regimen for osteosarcoma * No concurrent participation in another COG therapeutic study