Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma
About this trial
This is an interventional treatment trial for Adult Rhabdomyosarcoma
Eligibility Criteria
Inclusion Criteria:
- Patients must be eligible for, and enrolled on D9902 prior to enrollment on ARST08P1
- Patients with newly diagnosed, biopsy-proven metastatic rhabdomyosarcoma or ectomesenchymoma (stage IV, clinical group IV) are eligible for this study; patients with stage IV, clinical group IV RMS with parameningeal and paraspinal primary tumors, including those with intracranial extension (ICE) are eligible for ARST08P1; ICE is defined by contrast magnetic resonance imaging (MRI) showing that the primary tumor touches, displaces, invades, distorts, or otherwise causes signal abnormality of the dura in brain or spinal cord in contiguity to the primary site; ICE is also presumed to exist if the cerebrospinal fluid (CSF) cytopathology is positive for tumor at diagnosis
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
- No prior chemotherapy or radiotherapy except for use of corticosteroids or emergent radiation therapy; patients requiring emergency radiation are eligible
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73m^2 OR maximum serum creatinine based on age/gender as follows:
- 0.4 mg/dL (for patients 1 to 5 months of age)
- 0.5 mg/dL (for patients 6 to 11 months of age)
- 0.6 mg/dL (for patients 1 year of age)
- 0.8 mg/dL (for patients 2 to 5 years of age)
- 1.0 mg/dL (for patients 6 to 9 years of age)
- 1.2 mg/dL (for patients 10 to 12 years of age)
- 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
- 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients >= 16 years of age)
- Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, unless there is evidence of biliary obstruction by the tumor
- Shortening fraction >= 27% by echocardiogram (ECHO) OR ejection fraction >= 50% by radionuclide angiogram
- Absolute neutrophil count (ANC) >= 750/uL; abnormal blood counts are permissible if there is bone marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma
- Platelet count >= 75,000/uL; abnormal blood counts are permissible if there is bone marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma
- Sexually active patients of childbearing potential must agree to use effective contraception during therapy (Pilots 1 and 2) and for at least 3 months after the last dose of IMC-A12 (Pilots 1)
Exclusion Criteria:
- Female patients who are pregnant are not eligible
- Female patients who are breastfeeding are not eligible; female patients who are lactating must agree to stop breastfeeding to participate in this study
- Patients receiving growth hormone therapy are not eligible
- Patients with known type I or type II diabetes mellitus are not eligible for enrollment on Pilot 1
- Patients with evidence of uncontrolled infection are not eligible
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Sites / Locations
- Children's Hospital of Alabama
- University of Alabama at Birmingham Cancer Center
- Phoenix Childrens Hospital
- Arkansas Children's Hospital
- Southern California Permanente Medical Group
- Miller Children's and Women's Hospital Long Beach
- Children's Hospital Los Angeles
- David Geffen School of Medicine at UCLA
- Mattel Children's Hospital UCLA
- Children's Hospital Central California
- Children's Hospital and Research Center at Oakland
- Kaiser Permanente-Oakland
- Childrens Hospital of Orange County
- Lucile Packard Children's Hospital Stanford University
- Rady Children's Hospital - San Diego
- UCSF Medical Center-Parnassus
- Children's Hospital Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
- Connecticut Children's Medical Center
- Yale University
- Alfred I duPont Hospital for Children
- MedStar Georgetown University Hospital
- Children's National Medical Center
- Broward Health Medical Center
- Golisano Children's Hospital of Southwest Florida
- Memorial Healthcare System - Joe DiMaggio Children's Hospital
- Nemours Children's Clinic-Jacksonville
- Nemours Children's Hospital
- Nemours Children's Clinic - Pensacola
- All Children's Hospital
- Saint Joseph's Hospital/Children's Hospital-Tampa
- Saint Mary's Hospital
- Children's Healthcare of Atlanta - Egleston
- University of Hawaii Cancer Center
- Saint Luke's Mountain States Tumor Institute
- Lurie Children's Hospital-Chicago
- University of Chicago Comprehensive Cancer Center
- Loyola University Medical Center
- Saint Jude Midwest Affiliate
- Southern Illinois University
- Riley Hospital for Children
- Blank Children's Hospital
- University of Kentucky/Markey Cancer Center
- Kosair Children's Hospital
- Tulane University Health Sciences Center
- Children's Hospital New Orleans
- Sinai Hospital of Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Walter Reed National Military Medical Center
- Dana-Farber Cancer Institute
- C S Mott Children's Hospital
- Wayne State University/Karmanos Cancer Institute
- Helen DeVos Children's Hospital at Spectrum Health
- Bronson Methodist Hospital
- Kalamazoo Center for Medical Studies
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- University of Minnesota Medical Center-Fairview
- Mayo Clinic
- University of Mississippi Medical Center
- The Childrens Mercy Hospital
- Cardinal Glennon Children's Medical Center
- Washington University School of Medicine
- Saint John's Mercy Medical Center
- Nevada Cancer Research Foundation CCOP
- Hackensack University Medical Center
- Morristown Memorial Hospital
- UMDNJ - Robert Wood Johnson University Hospital
- Newark Beth Israel Medical Center
- Saint Joseph's Regional Medical Center
- Overlook Hospital
- University of New Mexico Cancer Center
- University of New Mexico
- Albany Medical Center
- The Steven and Alexandra Cohen Children's Medical Center of New York
- New York University Langone Medical Center
- University of Rochester
- State University of New York Upstate Medical University
- University of North Carolina at Chapel Hill
- Carolinas Medical Center
- Duke University Medical Center
- Wake Forest University Health Sciences
- 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
- Mercy Children's Hospital
- University of Oklahoma Health Sciences Center
- Natalie Warren Bryant Cancer Center at Saint Francis
- Legacy Emanuel Children's Hospital
- Legacy Emanuel Hospital and Health Center
- Oregon Health and Science University
- Lehigh Valley Hospital - Muhlenberg
- Penn State Hershey Children's Hospital
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh of UPMC
- Rhode Island Hospital
- Medical University of South Carolina
- Palmetto Health Richland
- BI-LO Charities Children's Cancer Center
- Greenville Cancer Treatment Center
- Sanford USD Medical Center - Sioux Falls
- East Tennessee Childrens Hospital
- St. Jude Children's Research Hospital
- Vanderbilt University/Ingram Cancer Center
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Cook Children's Medical Center
- Baylor College of Medicine
- Primary Children's Hospital
- University of Vermont College of Medicine
- Childrens Hospital-King's Daughters
- Virginia Commonwealth University/Massey Cancer Center
- Seattle Children's Hospital
- Providence Sacred Heart Medical Center and Children's Hospital
- Mary Bridge Children's Hospital and Health Center
- West Virginia University Charleston
- Saint Vincent Hospital
- Midwest Children's Cancer Center
- Sydney Children's Hospital
- The Children's Hospital at Westmead
- Royal Brisbane and Women's Hospital
- Royal Children's Hospital-Brisbane
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- British Columbia Children's Hospital
- CancerCare Manitoba
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Chedoke-McMaster Hospitals
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- The Montreal Children's Hospital of the MUHC
- Centre Hospitalier Universitaire Sainte-Justine
- Saskatoon Cancer Centre
- Centre Hospitalier Universitaire de Quebec
- Starship Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1 (chemotherapy, radiation therapy, cixutumumab)
Group 2 (chemotherapy, radiation therapy, temozolomide)
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50, and 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47, and 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, and 30; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28, and 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41, and 44; dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41, and 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiation therapy on days 1-5 of weeks 20-24.
Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiation therapy as in group 1. Patients also receive temozolomide PO on days 1-5 of weeks 1, 4, 20, 23, 47, and 50.