Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
Stage I Adrenal Cortical Carcinoma AJCC v7, Stage II Adrenal Cortical Carcinoma AJCC v7, Stage III Adrenal Cortical Carcinoma AJCC v7
About this trial
This is an interventional treatment trial for Stage I Adrenal Cortical Carcinoma AJCC v7
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
Sites / Locations
- Children's Hospital of Alabama
- University of Alabama at Birmingham Cancer Center
- Banner University Medical Center - Tucson
- University of Arkansas for Medical Sciences
- Kaiser Permanente Downey Medical Center
- Miller Children's and Women's Hospital Long Beach
- Children's Hospital Los Angeles
- Valley Children's Hospital
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital Stanford University
- Children's Hospital Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
- University of Connecticut
- Connecticut Children's Medical Center
- Alfred I duPont Hospital for Children
- Children's National Medical Center
- Lee Memorial Health System
- Nemours Children's Clinic-Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Nemours Children's Clinic - Orlando
- Nemours Children's Clinic - Pensacola
- Sacred Heart Hospital
- Johns Hopkins All Children's Hospital
- Saint Joseph's Hospital/Children's Hospital-Tampa
- Saint Mary's Hospital
- Tripler Army Medical Center
- Lurie Children's Hospital-Chicago
- University of Chicago Comprehensive Cancer Center
- Saint Jude Midwest Affiliate
- Southern Illinois University School of Medicine
- Indiana University/Melvin and Bren Simon Cancer Center
- Riley Hospital for Children
- University of Kentucky/Markey Cancer Center
- Norton Children's Hospital
- Tulane University Health Sciences Center
- Sinai Hospital of Baltimore
- Walter Reed National Military Medical Center
- Dana-Farber Cancer Institute
- Wayne State University/Karmanos Cancer Institute
- Michigan State University Clinical Center
- University of Minnesota/Masonic Cancer Center
- Children's Mercy Hospitals and Clinics
- Washington University School of Medicine
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Nevada Cancer Research Foundation NCORP
- Hackensack University Medical Center
- Morristown Medical Center
- Newark Beth Israel Medical Center
- Overlook Hospital
- Albany Medical Center
- University of Rochester
- New York Medical College
- UNC Lineberger Comprehensive Cancer Center
- Duke University Medical Center
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Childrens Hospital
- Cleveland Clinic Foundation
- Nationwide Children's Hospital
- Dayton Children's Hospital
- University of Oklahoma Health Sciences Center
- Geisinger Medical Center
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh of UPMC
- Prisma Health Richland Hospital
- BI-LO Charities Children's Cancer Center
- Greenville Cancer Treatment Center
- Saint Jude Children's Research Hospital
- Driscoll Children's Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Cook Children's Medical Center
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Methodist Children's Hospital of South Texas
- University of Texas Health Science Center at San Antonio
- Primary Children's Hospital
- University of Vermont and State Agricultural College
- University of Virginia Cancer Center
- Children's Hospital of The King's Daughters
- Seattle Children's Hospital
- West Virginia University Charleston Division
- Children's Hospital of Wisconsin
- Princess Margaret Hospital for Children
- Boldrini Children's Cancer Center
- Instituto De Oncologia Pediatrica
- Alberta Children's Hospital
- British Columbia Children's Hospital
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Hospital for Sick Children
- Centre Hospitalier Universitaire Sainte-Justine
- Centre Hospitalier Universitaire de Quebec
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Stratum I (surgery, observation)
Stratum II (exploratory surgery, observation)
Stratum III (chemotherapy, surgery)
Patients undergo primary tumor resection and retroperitoneal lymph node sampling followed by observation. Patients who have undergone prior surgery without nodal sampling undergo observation only.
Patients undergo primary tumor resection and extended regional lymph node dissection followed by observation. Patients who have undergone prior surgery with simple resection of the primary tumor undergo exploratory surgery with extended regional lymph node dissection followed by observation.
Patients receive combination chemotherapy with filgrastim (G-CSF) for up to 30 weeks (10 courses) followed by mitotane alone for an additional 2 months. Some patients undergo surgery after chemotherapy course 2 or 4. Some patients undergo additional surgery after finishing all chemotherapy.