Clinical trial · Interventional
Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Dose Finding Study of Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung
NCT00017121CI-TRIAL-00022868completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sargramostim
- description
- Patients receive aerosolized sargramostim (GM-CSF) twice a day on days 1-7 and 15-21. Treatment repeats every 28 days for 2 courses. Patients with no disease progression after completion of course 2 may continue on treatment until disease progression. Patients are grouped to 1 of 2 dose-escalation regimens (part A vs B). After completion of study therapy, patients are followed at 3 months, every 2 months for 1 year, and then every 3-4 months for 5 years.
- interventionNames
- Biological: sargramostim
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Up to 6 years
Secondary outcomes (3)
- measure
- Progression-free survival
- timeFrame
- Up to 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma to the lung for which no known standard therapy exists * At least 1 unidimensionally measurable lesion * HLA-A2 positive (part A patients only) * Previously treated CNS metastases allowed provided there is no evidence of disease progression within the past 3 months PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 2.5 times ULN Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * No pulmonary disease requiring concurrent active therapy (e.g., supplemental oxygen or bronchodilator) * FEV\_1 at least 65% of predicted and at least 1.5 L Immunologic: * No known immunodeficiency state * No known autoimmune disease * No uncontrolled infection Other: * No active psychotic disorder requiring pharmacotherapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 2 weeks since prior biologic therapy * More than 2 weeks since prior immunotherapy * More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * No other concurrent biologic therapy or immunotherapy * No concurrent G-CSF * No concurrent GM-CSF other than study drug Chemotherapy: * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No concurrent chemotherapy Endocrine therapy: * More than 2 weeks since prior corticosteroids * No concurrent glucocorticosteroids Radiotherapy: * More than 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * More than 7 days since prior parenteral antibiotics * No concurrent parenteral antibiotics * No concurrent immunosuppressive agents
References
Publications (2)
- RESULTMarkovic 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. PMID 19060590
- RESULTMarkovic 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.