Clinical Trial: Surgery and Heated Chemotherapy for Adrenocortical Carcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

Brief Summary:

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.

Detailed Summary:

Background:

- Adrenocortical carcinoma (ACC) is a rare tumor with an incidence of 1.5 to 2 per

million people per year and has a very poor prognosis 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. For unresectable metastatic or recurrent disease, mitotane,

aminoglutethimide, metapyrone, and ketoconazole are used.

- Cisplatin is one of the most effective chemotherapeutic agents for ACC. In the

Surgery Branch we have conducted Phase I and II trials using heated intraperitoneal

(IP) chemotherapy with cisplatin for primary peritoneal mesothelioma, low grade

appendiceal adenocarcinoma, ovarian malignancies, and high grade adenocarcinoma

of the gastrointestinal tract. Synergy has been demonstrated for cisplatin and

hyperthermia

- The purpose of this trial is to determine if an aggressive surgical approach with

intraperitoneal administration of heated cisplatin when tumor volume is minimal, can

impact and improve on progression free survival.

Objectives:

  • Determine morbidity of this procedure in this patient population [ Time Frame: 5 years ]
  • Determine the impact of surgery and HIPEC on QOL [ Time Frame: 5 years ]
  • Determine the impact of surgery and HIPEC on hormone excess [ Time Frame: 5 years ]
  • Examine patterns of recurrence (local versus systemic) [ Time Frame: 5 years ]
  • Perform molecular analyses to try to discern if there are intrinsic differences between tumors that recur widely throughout the peritoneal surface and those that metastasize to other organs or are confined to a local recurrence. [ Time Frame: 5 years ]
  • Determine overall survival after optimal debulking and heated intraperitoneal chemotherapy with cisplatin in patients with intraperitoneal spread of adrenocortical cancer [ Time Frame: 5 years ]


    • Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: April 12, 2013
    Date Started: April 4, 2013
    Date Completion: May 1, 2019
    Last Updated: May 12, 2017
    Last Verified: March 24, 2017