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.
Adrenocortical carcinoma (ACC) is an exceptionally rare tumor with a very poor prognosis. The best treatment of these tumors is surgical resection, and repeat operations if the tumors recur. For tumors that cannot be resected, a few drugs given intravenously exist to help slow the progression of the disease. Cisplatin given intravenously is among the most effective drugs for ACC. In studies of other tumor types, heated Cisplatin administered directly into the abdomen at the time of surgery to remove all visible tumor deposits has been shown to effectively treat the tumor over surgery alone or drugs being given intravenously. The purpose of this study is to better understand if surgical resection of all visible disease with intraperitoneal administration of heated cisplatin can improve outcomes from metastatic ACC. Additionally, the investigators would like to understand associated complications, how quality of life is affected, and if there are specific tumor factors that affect survival and recurrence after this procedure. To be eligible for the study, participants must have ACC that can be seen on CT imaging. A surgeon must believe the disease can be safely removed, and that the patient can tolerate the operation and potential complications. Patients who are successfully debulked of visible tumor will undergo heated intra-abdominal chemotherapy with Cisplatin at the same operation. Associate investigators in coordination with the Principal Investigator will evaluate patients over 18 years of age for eligibility. This investigation aims to improve quality and length of life in patients with limited options for the treatment of metastatic ACC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Route of administration: Intraperitoneal for tumor treatment. Dose of 250 mg/m2 Drug 1 of the hyperthermic intraperitoneal chemotherapy (HIPEC)
Route of administration: Intravenous Loading dose of 7.5 gm/m2 over 20 minutes followed by 2.13 gm/m2/hr for 12 hours Drug 2 given intravenously during hyperthermic intraperitoneal chemotherapy (HIPEC)
Standard of care: Surgical procedure used to remove tumors from patients with peritoneal tumors.
Columbia University Medical Center
New York, New York, United States
Progression Free Survival
The length of time after optimal debulking and heated intraperitoneal chemotherapy that a patient lives before there is clinical evidence of recurrent adrenocortical cancer.
Time frame: Up to 5 years
Morbidity Rate
The frequency of post-operative complications.
Time frame: Up to 5 years
Quality of Life (QOL) Score
This measures the impact of surgery and HIPEC on quality of life.
Time frame: Up to 5 years
Overall Survival
The length of time people are alive after surgery and HIPEC for adrenocortical cancer.
Time frame: Up to 5 years
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