Phase 2 trial of cixutumumab in children, adolescents, and young adults with refractory solid tumors: A report from the Children's Oncology Group
Year: 2013
Type: article
Study design: Clinical Trial
Abstract: PURPOSE: This phase 2 study was designed to assess the efficacy of single agent cixutumumab (IMC-A12) and gain further information about associated toxicities and pharmacodynamics in children, adolescents, and young adults with recurrent or refractory solid tumors. PATIENTS AND METHODS: Patients with relapsed or refractory solid tumors were treated with 9 mg/kg of cixutumumab as a 1-hour IV infusion once weekly. Strata included: osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, neuroblastoma (evaluable disease), neuroblastoma (measurable disease), Wilms tumor, adrenocortical carcinoma, synovial sarcoma, hepatoblastoma, and retinoblastoma. Correlative studies in consenting patients included an assessment of c-peptide, IGFBP-3, IGF-1, IGF-2, hGH, and insulin in consenting patients. RESULTS: One hundred sixteen patients with 114 eligible having a median age of 12 years (range, 2-30) were enrolled. Five patients achieved a partial response: 4/20 with neuroblastoma (evaluable only) and 1/20 with rhabdomyosarcoma. Fourteen patients had stable disease for a median of 10 cycles. Hematologic and non-hematologic toxicities were generally mild and infrequent. Serum IGF-1 and IGFBP-3 increased in response to therapy with cixutumumab. CONCLUSION: Cixutumumab is well tolerated in children with refractory solid tumors. Limited objective single-agent activity of cixutumumab was observed; however, prolonged stable disease was observed in 15% of patients. Ongoing studies are evaluating the toxicity and benefit of cixutumumab in combination with other agents that inhibit the IGF pathway.
Source: Pediatric Blood & Cancer
DOI: 10.1002/pbc.24605
Institutions: University of Minnesota, Oregon Health & Science University, Mayo Clinic, Boston Children's Hospital, Harvard University, Dana-Farber Cancer Institute, Johns Hopkins University, Johns Hopkins Hospital, National Cancer Institute, University of Southern California, Children's Oncology Group, Children's Hospital of Philadelphia, Baylor College of Medicine
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G301932103, Children's Oncology Group Statistics and Data Center Grant, G305172255, G3829775219, Children's Oncology Group Statistics and Data Center, G4983611102, COG NCTN Network Group Operations Center, General Clinical Research Center, Children's Oncology Group Phase 1 / Pilot Consortium, Children's Oncology Group Chair's Grant, G8563744204, Mayo Clinic Comprehensive Cancer Center Support Grant
OpenAlex ID: W1491888133