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Villages of Oriole, FL, United States

Kim A.,Childrens National Medical Center | Widemann B.C.,U.S. National Cancer Institute | Krailo M.,Childrens Oncology Group Statistics | Jayaprakash N.,U.S. National Cancer Institute | And 3 more authors.
Pediatric Blood and Cancer | Year: 2015

Background: Sorafenib is an oral small molecule inhibitor of multiple kinases controlling tumor growth and angiogenesis. The purpose of the phase 2 study was to determine the response rate of sorafenib and gain further information on the associated toxicities, pharmacokinetics, and pharmacodynamics of sorafenib in children and young adults with relapsed or refractory tumors including rhabdomyosarcoma, Wilms tumor, hepatocellular carcinoma (HCC), and papillary thyroid carcinoma (PTC). Procedure: Sorafenib, 200mg/m2/dose, was administered every 12hr continuously for 28 day cycles using a two-stage design in two primary strata (rhabdomyosarcoma and Wilms tumor) and two secondary strata (HCC and PTC). Correlative studies in consenting patients included determination of sorafenib steady state trough concentrations and assessments of VEGF and sVEGFR2. Results: Twenty patients (median age of 11 years; range, 5-21) enrolled. No objective responses (RECIST) were observed in the 10 evaluable patients enrolled in each of the two primary disease strata of rhabdomyosarcoma and Wilms tumor. No patients with HCC or PTC were enrolled. Sorafenib was not associated with an excessive rate of dose-limiting toxicity (DLT). The mean±SD steady state concentration during cycle 1 day 15 was 6.5±3.9μg/ml (n=10). Conclusions: Sorafenib was well tolerated in children at 200mg/m2/dose twice daily on a continuous regimen with toxicity profile and steady state drug concentrations similar to those previously reported. Single agent sorafenib was inactive in children with recurrent or refractory rhabdomyosarcoma or Wilms tumor. Pediatr Blood Cancer 2015;62:1562-1566. © 2015 Wiley Periodicals, Inc. Source

Devidas M.,Childrens Oncology Group Statistics | Devidas M.,University of Florida | London W.B.,Childrens Oncology Group Statistics | London W.B.,Dana-Farber Cancer Institute | And 2 more authors.
Seminars in Oncology | Year: 2010

The Children's Oncology Group (COG) is a National Cancer Institute (NIH)-sponsored cooperative clinical trials group with the primary mission of conducting pediatric cancer clinical trials. COG has complex risk classification systems that are used to deliver risk-stratified therapy for many pediatric cancers, including clinical trials for acute lymphoblastic leukemia (ALL) and neuroblastoma (NB). Classification of patients is based on biological, clinical, and genomic data obtained at initial diagnosis and during the initial phases of therapy. The COG Web-based remote data entry (RDE) system enables submission of data in real time from central laboratories and treating institutions. The data are then used in an automated fashion to determine the risk group and corresponding treatment assignment for individual patients enrolled in COG clinical trials. © 2010 Elsevier Inc. All rights reserved. Source

Marina N.,Stanford University | Granowetter L.,New York University | Grier H.E.,Pediatric Hematology Oncology | Womer R.B.,Childrens Hospital of Philadelphia | And 6 more authors.
Sarcoma | Year: 2015

Purpose. To associate baseline patient characteristics and relapse across consecutive COG studies. Methods. We analyzed risk factors for LESFT patients in three randomized COG trials. We evaluated age at enrollment, primary site, gender, tumor size, and treatment (as randomized). We estimated event-free survival (EFS, Kaplan-Meier) and compared risk across groups (log-rank test). Characteristics were assessed by proportional hazards regression with the characteristic of interest as the only component. Confidence intervals (CI) for RR were derived. Factors related to outcome at level 0.05 were included in a multivariate regression model. Results. Between 12/1988 and 8/2005, 1444 patients were enrolled and data current to 2001, 2004, or 2008 were used. Patients were with a median age of 12 years (0-45), 55% male and 88% Caucasian. The 5-year EFS was 68.3% ± 1.3%. In univariate analysis age, treatment, and tumor location were identified for inclusion in the multivariate model, and all remained significant (p < 0.01). Since tumor size was not collected in the last study, the other two were reanalyzed. This model identified age, treatment, tumor location, and tumor size as significant predictors. Conclusion. Age > 18 years, pelvic tumor, size > 8 cms, and chemotherapy without ifosfamide/etoposide significantly predict worse outcome. AEWS0031 is NCT00006734, INT0091 and INT0054 designed before 1993 (unregistered). © 2015 Neyssa Marina et al. Source

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