drugset / Trial / NCT00017121
Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Phase 1
Completed
40 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Inhaling sargramostim may interfere with the growth of tumor cells and may be an effective treatment for melanoma that has spread to the lung. PURPOSE: This phase I trial is studying the side effects and best dose of inhaled sargramostim in treating patients with melanoma that is metastatic to the lung.
Timeline
- Start
- 2002-05
- Primary completion
- 2012-11
- Completion
- 2012-11
Publications
- Results Markovic SN, Suman VJ, Nevala WK, Geeraerts L, Creagan ET, Erickson LA, Rowland KM Jr, Morton RF, Horvath WL, Pittelkow MR. A dose-escalation study of aerosolized sargramostim in the treatment of metastatic melanoma: an NCCTG Study. Am J Clin Oncol. 2008 Dec;31(6):573-9. doi: 10.1097/COC.0b013e318173a536.
- Results Markovic SN, Suman VJ, Schaefer P, et al.: Aerosolized sargramostim for the treatment of metastatic melanoma to the lungs. [Abstract] J Clin Oncol 25 (Suppl 18): A-8565, 488s, 2007.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sargramostim | Protein / enzyme biologic | 500 ug | Inhaled |
| Subject | sargramostim | Protein / enzyme biologic | 750 ug | Inhaled |
| Subject | sargramostim | Protein / enzyme biologic | 1000 ug | Inhaled |
| Subject | sargramostim | Protein / enzyme biologic | 1250 ug | Inhaled |
| Subject | sargramostim | Protein / enzyme biologic | 1500 ug | Inhaled |
| Subject | sargramostim | Protein / enzyme biologic | 1750 ug | Inhaled |
| Subject | sargramostim | Protein / enzyme biologic | 2000 ug | Inhaled |