SCH 58500 + cisplatin + vinorelbine

SCH 58500 + cisplatin + vinorelbine is a combination therapy that includes a gene therapy agent (SCH 58500) and two chemotherapy drugs (cisplatin and vinorelbine). ## What is SCH 58500? SCH 58500 is a recombinant, replication-deficient adenoviral vector containing the cloned human wild-type (normal) tumor suppressor gene p53[1][3]. It was developed as a gene therapy approach for treating various types of cancer, particularly those expressing mutant p53 phenotypes[3][5]. The mechanism of action involves delivering the functional p53 gene into tumor cells to inhibit the growth of tumor cells that express the mutated p53 gene[7]. Loss of wild-type p53 function can lead to uncontrolled cell growth and development of several tumor types, making p53 restoration a potential therapeutic strategy[3]. ## Clinical Development SCH 58500 was developed by Schering-Plough Corp. and Canji[2][6]. It underwent clinical trials for multiple cancer indications: - Phase II/III clinical trials for stage III ovarian cancer[6] - Phase II clinical trials for hepatocellular and colorectal cancer metastatic to the liver[6] - Phase I clinical trials for several other types of cancer[6] The drug was administered through various routes depending on the tumor type: - Intratumoral administration for breast, melanoma, head, neck, and non-small-cell lung tumors - Intraperitoneal administration for ovarian tumors - Hepatic artery administration for liver tumors[3][5] A Phase I/II trial investigated SCH 58500 delivered intraperitoneally alone and in combination with platinum-based chemotherapy for patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer containing aberrant or mutant p53[8]. The study found that intraperitoneal SCH 58500 was safe, well-tolerated, and when combined with platinum-based chemotherapy, could be associated with significant reduction of serum CA125 in heavily pretreated patients[8]. ## Combination with Cisplatin and Vinorelbine While the search results don't specifically mention the combination of SCH 58500 with both cisplatin and vinorelbine together, they do indicate that SCH 58500 was studied in combination with platinum-based chemotherapy (which includes cisplatin)[8]. The combination of SCH 58500 with cisplatin and vinorelbine would represent a treatment approach combining gene therapy (targeting p53) with traditional chemotherapy agents. ## Current Status Based on the search results, it appears that development of SCH 58500 has been discontinued[2]. The highest development phase reached was Phase 2/3[2].