Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
Condition: Stage I Adrenal Cortical Carcinoma AJCC v7; Stage II Adrenal Cortical Carcinoma AJCC v7; Stage III Adrenal Cortical Carcinoma AJCC v7; Stage IV Adrenal Cortical Carcinoma AJCC v7
MeSH terms: Carcinoma; Adrenocortical Carcinoma; Adrenal Cortex Neoplasms
Intervention: Cisplatin; Conventional Surgery; Doxorubicin Hydrochloride; Etoposide; Filgrastim; Mitotane; Pegfilgrastim
Intervention description: Given IV; Patients undergo surgery; Given IV; Given IV; Given subcutaneously; Given orally; Given subcutaneously
Intervention MeSH terms: Cisplatin; Doxorubicin; Liposomal doxorubicin; Etoposide; Etoposide phosphate; Podophyllotoxin; Mitotane; Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or
      surgery works in treating young patients with stage I, stage II, stage III or stage IV
      adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways
      to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
      Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal
      tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain
      after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adrenocortical carcinoma

               -  Newly diagnosed disease within the past 3 weeks

               -  Any disease stage allowed

          -  Lansky performance status 60-100% (for patients ≤ 16 years old)

          -  Karnofsky performance status 60-100% (for patients > 16 years old)

          -  Absolute neutrophil count ≥ 750/mm^3

          -  Platelet count ≥ 75,000/mm^3

          -  Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum
             creatinine based on age as follows:

               -  0.4 mg/dL (1 month to < 6 months)

               -  0.5 mg/dL (6 months to < 1 year of age)

               -  0.6 mg/dL (1 to < 2 years of age

               -  0.8 mg/dL (2 to < 6 years of age)

               -  1.0 mg/dL (6 to < 10 years of age)

               -  1.2 mg/dL (10 to < 13 years of age)

               -  1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)

               -  1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST or ALT < 2.5 times ULN

          -  Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide
             angiogram

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No previous chemotherapy for adrenocortical carcinoma