At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed osteosarcoma at primary diagnosis
- ✓Metastatic lesions in at least 1 lung consistent with metastatic disease and approachable with thoracotomy
- ✓Pulmonary nodules resectable without pneumonectomy
- ✓Age 39 and under
- ✕Prior recurrence of osteosarcoma
- ✕Other sites of metastases beyond lungs
- ✕Pleural effusion or pleural-based nodules
- ✕Evidence of dyspnea at rest or exercise intolerance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND# 11042) in Patients With First Pulmonary Recurrence of Osteosarcoma
In Brief
A Phase 2 clinical trial evaluating sargramostim and conventional surgery for Metastatic Cancer and Sarcoma. Completed, enrolled 49 participants across 93 sites in 4 countries.
Detailed Summary
RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma that has spread to the lung. PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.
Study Details
Timeline
Interventions
given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
thoracotomy