drugset / Trial / NCT03127774

Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

NCT03127774

Phase 2 Active not recruiting 30 enrolled Columbia University
NaSingle-groupOpen-labelTreatment

Summary

Adrenocortical carcinoma (ACC) is a rare tumor with an overall 5-year mortality rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months. The treatment of choice for a localized primary or recurrent tumor is surgical resection of all visible tumor and involved organs. For unresectable metastatic or recurrent disease, mitotane, aminoglutethimide, metapyrone, and ketoconazole are used. This would be the standard of care alternative treatment. Cisplatin is one of the most effective chemotherapeutic agents for ACC. Phase I and II trials using heated intraperitoneal (IP) chemotherapy with cisplatin have been conducted in other tumors that spread primarily to the peritoneal lining of the abdomen. Synergy has been demonstrated for cisplatin and hyperthermia. The purpose of this trial is to determine if a surgical approach with intraperitoneal administration of heated cisplatin when tumor volume is minimal, can impact and improve on progression free survival.

Timeline

Start
2017-09-22
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 250 mg/m2 Other
Background Sodium Thiosulfate Diagnostic / imaging agent 2130 mg/m2 Intravenous