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Updated: Jan 30, 2026

Isolation of Exosome-Enriched Extracellular Vesicles Carrying Granulocyte-Macrophage Colony-Stimulating Factor from Embryonic Stem Cells
Published on: November 11, 2021
Immunotherapy of renal cell carcinoma with granulocyte macrophage colony stimulating factor and very low dose
Pierpaolo Correale1, Stefania Marsili, Marianna Sabatino
1Interdipartimental Oncopharmacology Center, Faculty of Medicine, University of Siena, Viale Bracci 11, 53100 Siena, Italy.
Abstract:
We have performed a translational phase II trial testing an original immunotherapy schedule based on the monthly subcutaneous (s.c.) administration of hrGM-CSF (days 1 through 5) and very low dose hrIL-2 (days 6 through 15) in 19 patients with metastatic renal cell carcinoma. Bone pain, first dose reaction to GM-CSF, asthenia and fever were the most common side effects. A partial response, and a disease stabilization were respectively observed in 4 and 11 cases, with a rate of objective response and a disease control rate respectively of 21% and 79%. We recorded a time to progression of 9 months and a 2- and 3-year survival respectively of 42% (8/19 patients) and 26% (5/19 patients). Our results suggest that this GM-CSF/hrIL-2 combination is active and well tolerated in patients with renal cell carcinoma and deserves to be investigated in larger comparative trials.
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