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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