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Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
Bu çalışma, bir kemik kanseri olan osteosarkomun (osteosarcoma) ilk kez akciğere yayıldığı (akciğer nüksü) hastalarda, solunarak alınan sargramostim ilacını ve cerrahiyi incelemiştir. Çalışmaya, histolojik olarak doğrulanmış osteosarkomu olan, akciğerde ameliyatla çıkarılabilir nodülleri bulunan 39 yaş ve altındaki hastalar katılabilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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