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fluorouracil + sodium phenylbutyrate + indomethacin + interferon gamma-1b
- Development stage
- Phase 2
- Lead developer
- National Cancer Institute
- Modality
- Cytokines & Interferons → Recombinant Proteins and Enzymes, Small Molecules
- Administration
- Intravenous, Oral, Subcutaneous
01
Overview
This combination therapy is an experimental regimen developed and studied by the National Cancer Institute (NCI) for the treatment of advanced or Stage IV colorectal cancer. The regimen integrates cytotoxic chemotherapy, epigenetic modulation, and immunotherapy. Fluorouracil (5-FU) serves as the backbone, acting as an antimetabolite that inhibits thymidylate synthase to impair DNA synthesis. Sodium phenylbutyrate is included as a histone deacetylase (HDAC) inhibitor to promote cell differentiation and potentially reverse chemoresistance. Indomethacin, a nonsteroidal anti-inflammatory drug (NSAID), is utilized to inhibit cyclooxygenase (COX) enzymes, thereby reducing pro-inflammatory prostaglandins that can promote tumor growth and immune evasion. Recombinant human interferon-gamma (interferon gamma-1b) is added as an immunomodulatory cytokine to enhance the host's antitumor immune response and potentially sensitize tumor cells to the effects of the other agents. This multi-pronged approach was evaluated in Phase I/II clinical trials to determine the optimal dosing and safety profile in patients with metastatic disease.
- Other names
- 5-FU + Phenylbutyrate + Indomethacin + IFN-gammaFluorouracil + Phenylbutyrate + Indomethacin + Interferon-Gamma
02
Targets
HDAC (HDAC family)PGHS-1 (Prostaglandin G/H Synthase 1)PTGS2 (Prostaglandin-Endoperoxide Synthase 2)TS (Thymidylate synthase)IFNGR1 (Interferon gamma receptor 1)IFNGR2 (Interferon gamma receptor 2)
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