Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
Condition: Adrenocortical Carcinoma; Peritoneal Carcinomatosis
MeSH terms: Carcinoma; Peritoneal Neoplasms; Adrenocortical Carcinoma
Study type: Interventional
Phase: Phase 2

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 description: 
      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:

      - To determine IP progression free survival after optimal debulking and heated IP
      chemotherapy with cisplatin in patients with IP spread of adrenocortical cancer

      Eligibility:

      - Histologically proven ACC evaluable by computed tomography (CT) imaging with the majority
      of disease confined to the peritoneal cavity and surgically resectable to a residual size of
      less than 1 cm or amenable to radiofrequency ablation in patients who are > 18 years of age.

      Design:

      - This is a classic phase 2 trial to determine efficacy of this therapeutic strategy in ACC.
      Patients will undergo cytoreductive surgery to achieve a CCR of 0 or 1.

      Patients who are successfully debulked will then undergo hyperthermic intraperitoneal
      chemotherapy (HIPEC) with cisplatin.

      Patients will be evaluated by associate investigators in coordination with the Principal
      Investigator for eligibility. Due to its exploratory nature, up to 30 patients may be
      enrolled to obtain 24 evaluable patients. (Patients must undergo successful debulking and
      HIPEC to be considered evaluable.)
    

Intervention name(s): Cisplatin; Cytoreductive surgery; sodium thiosulfate
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.; Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.; sodium thiosulfate will be given to limit the toxicity of cisplatin
Other intervention name(s): Platinol
Intervention MeSH terms: Sodium thiosulfate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Synergy for Cisplatin and Hyperthermia; Rare Tumor; Poor Prognosis