Surgery and Heated Chemotherapy for Adrenocortical Carcinoma

Completed · Phase 2

Conditions studied: Adrenocortical Carcinoma, Peritoneal Carcinomatosis

In brief

Background: \- Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who develop this disease live more than 5 years after being diagnosed. Those whose tumors have spread inside their abdomen may have an especially poor outcome. In these cases, traditional chemotherapy is not very effective. One possible new treatment is aggressive surgery with heated chemotherapy. This type of treatment has been more effective for other types of cancer in the abdomen. Researchers want to see this if approach can improve the outcomes of people with ACC. Objectives: \- To test the safety and effectiveness of surgery and heated chemotherapy for ACC. Eligibility: \- Individuals at least 18 years of age who have advanced ACC. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. Heart function tests will be given. Imaging studies will be used to locate the surgical sites before the operation. * Participants will have surgery to remove ACC tumor tissue. After the tumors have been removed, they will have heated chemotherapy with cisplatin. The heat may help weaken any remaining cancer cells and make them easier to destroy. It will also focus the treatment on the tumor sites, rather than the whole body. * Participants will recover in the hospital for several days after surgery. They will have regular follow-up visits to monitor the outcome of the surgery.

Key facts

Study ID

NCT01833832

Run by

National Cancer Institute (NCI)

People needed

11

Starts

2013-04-12

Expected to finish

2018-08-09

Last updated by the study team

2019-07-30

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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 low-density lipoproteins (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 (PFTs) indicating an forced expiratory volume 1 (FEV1) less than 50% or a Carbon monoxide diffusing capacity (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

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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