Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

Not Recruiting

Trial ID: NCT00304070

Purpose

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.

Official Title

Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study

Stanford Investigator(s)

Eligibility


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

Intervention(s):

biological: filgrastim

drug: cisplatin

drug: doxorubicin hydrochloride

drug: etoposide

drug: mitotane

procedure: conventional surgery

biological: Pegfilgrastim

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pediatric Hematology/Oncology
650-723-5535

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