Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

NCT03127774 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAQ9194
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adrenocortical Carcinoma; Peritoneal Carcinomatosis

Keywords

Cisplatin; Heated Cisplatin

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 5 years

Secondary Outcomes (3)

• Morbidity Rate

  Up to 5 years

• Quality of Life (QOL) Score

  Up to 5 years

• Overall Survival

  Up to 5 years

Study Arms (1)

Surgery with HIPEC

EXPERIMENTAL

Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate

Drug: Cisplatin; Drug: Sodium thiosulfate; Procedure: Cytoreductive surgery

Interventions

Cisplatin DRUG

Route of administration: Intraperitoneal for tumor treatment. Dose of 250 mg/m2 Drug 1 of the hyperthermic intraperitoneal chemotherapy (HIPEC)

Also known as: Platinol

Surgery with HIPEC

Sodium thiosulfate DRUG

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)

Also known as: Sodium thiosulfate injection

Surgery with HIPEC

Cytoreductive surgery PROCEDURE

Standard of care: Surgical procedure used to remove tumors from patients with peritoneal tumors.

Also known as: Cytoreductive debulking surgery

Surgery with HIPEC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven ACC with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation
• Disease evaluable by CT or Positron Emission Tomography (PET) imaging
• All disease should be deemed resectable based on imaging studies e.g.:
• Hepatic metastases (unilateral or bilateral less than or equal to 5 lesions, less than or equal to 15 cm total diameter)
• Note: Hepatic lesions must be amenable to complete resection
• Primary peritoneal metastases (small disease load less than or equal to P2 disease) without massive ascites or intestinal obstruction
• Lung metastases (less than or equal to 3 unilateral/bilateral, 9 cm total diameter)
• Note: lung lesions must be amenable to complete resection
• Note: Patients with both pulmonary and hepatic metastases will be enrolled at the discretion of the PI
• Note: In situations where resection to Completeness of Cytoreduction Score (CC) 0 or 1 is uncertain, patients may undergo diagnostic laparoscopy prior to enrollment to determine feasibility of resection.
• Greater than or equal to 18 years of age
• Able to understand and sign the Informed Consent Document
• Clinical performance status of Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
• Life expectancy of greater than three months
• Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy

You may not qualify if:

• Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure.
• History of congestive heart failure and/or an left ventricular ejection fraction (LVEF) less than 40%
• Note: Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., greater than 65yo, diabetes, history of hypertension, elevated LDL, first degree relative with coronary artery disease) will undergo full cardiac evaluation and will not be eligible if they demonstrate significant irreversible ischemia on stress thallium or an ejection fraction less than 40%.
• \- Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function test (PFT) indicating an forced expiratory volume at one second (FEV1) less than 50% or a diffusing capacity of lung for carbon monoxide (DLCO) less than 40% predicted for age.
• Note: Patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will not be eligible if their FEV1 is less than 50% of expected.
• Grade 2 or greater neuropathy
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
• Brain metastases or a history of brain metastases
• Childs B or C cirrhosis
• Evidence of severe portal hypertension by history, endoscopy, or radiologic studies
• Note: Any diagnosis of portal hypertension or clinical stigmata of such including but not limited to gastric or esophageal varices, umbilical vein varices or telangiectasias.
• Weight less than 30 kg
• Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032-3729, United States

Location

MeSH Terms

Conditions

Adrenocortical Carcinoma; Peritoneal Neoplasms

Interventions

Cisplatin; sodium thiosulfate; Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Surgical Procedures, Operative

Study Officials

• Kazuki Sugahara, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: Patients who are successfully debulked will undergo heated intraperitoneal chemotherapy with cisplatin.

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: April 25, 2017
• Study Start: September 22, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)