First-in-Human Phase 1 Trial of Agarose Beads Containing Murine RENCA Cells in Advanced Solid Tumors
| Autor: | Allyson J. Ocean, Thomas J. Fahey, Angelica Nazarian, Zoe P. Andrada, Nathaniel Berman, Lawrence S. Gazda, Barry Smith, David J. Wolf, Madeline Wiles, Thomas S. Parker, Anna Arreglado, Daniel M. Levine, Eugene Akahoho, Tapan Parikh, Joanne Thomas |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Oncology medicine.medical_specialty gastrointestinal cancer cancer system biology lcsh:RC254-282 cancer clinical trial 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine colorectal cancer treatment medicine Gastrointestinal cancer cell-based therapeutics Laparoscopy Original Research medicine.diagnostic_test business.industry Cancer General Medicine First in human solid tumors lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens medicine.disease 030104 developmental biology chemistry 030220 oncology & carcinogenesis Cancer cell Drug delivery Agarose Implant business Biomedical engineering |
| Zdroj: | Cancer Growth and Metastasis, Vol 2016, Iss 9, Pp 9-20 (2016) Cancer Growth and Metastasis Cancer Growth and Metastasis, Vol 9 (2016) |
| ISSN: | 1179-0644 |
| DOI: | 10.4137/cgm.s39442 |
| Popis: | Purpose Agarose macrobeads containing mouse renal adenocarcinoma cells (RMBs) release factors, suppressing the growth of cancer cells and prolonging survival in spontaneous or induced tumor animals, mediated, in part, by increased levels of myocyte-enhancing factor (MEF2D) via EGFR-and AKT-signaling pathways. The primary objective of this study was to determine the safety of RMBs in advanced, treatment-resistant metastatic cancers, and then its efficacy (survival), which is the secondary objective. Methods Thirty-one patients underwent up to four intraperitoneal implantations of RMBs (8 or 16 macrobeads/kg) via laparoscopy in this single-arm trial (FDA BB-IND 10091; NCT 00283075). Serial physical examinations, laboratory testing, and PET-CT imaging were performed before and three months after each implant. Results RMBs were well tolerated at both dose levels (mean 660.9 per implant). AEs were (Grade 1/2) with no treatment-related SAEs. Conclusion The data support the safety of RMB therapy in advanced-malignancy patients, and the preliminary evidence for their potential efficacy is encouraging. A Phase 2 efficacy trial is ongoing. |
| Databáze: | OpenAIRE |
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