Safety Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of Bone

Status: Recruiting
Phase:
Diagnosis: Pediatric Sarcoma
NCT ID: NCT00680992 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-103

 

To determine how safe denosumab is in treating subjects with giant cell tumor of bone

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Edwin Choy, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Carol Sweeney, RN, 617-632-2639, carol_sweeney@dfci.harvard.edu

Eligibility Criteria

Key inclusion criteria: - Pathologically confirmed giant cell tumor of bone within 1 year before study enrollment - Measurable evidence of active disease within 1 year before study enrollment - Subjects with surgically unsalvageable disease (eg, sacral, spinal GCT, or multiple lesions including pulmonary metastases) OR subjects whose planned initial surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity, other than curettage with complete resection of tumor - Karnofsky performance status ≥ 50% (ie, ECOG status 0, 1, or 2) - Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone [eg, humerus with closed growth epiphyseal plate]) ≥ 12 years of age - Skeletally mature adolescents must weigh at least 45 kg - Before any study-specific procedure is performed, the appropriate written informed consent must be obtained Key exclusion criteria: - Currently receiving other GCT specific treatment (eg, radiation, chemotherapy, or embolization) - Concurrent bisphosphonate treatment - Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma - Known or suspected current diagnosis of non GCT giant cell-rich tumors - Known or suspected current diagnosis of brown cell tumor of bone - Known diagnosis of second malignancy within the past 5 years - Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw - Active dental or jaw condition which requires oral surgery - Non-healed dental/oral surgery - Planned invasive dental procedure for the course of the study - Women or men unwilling to use adequate contraceptive measures - Women of child-bearing potential are evidently pregnant (eg, positive HCG test) or breast feeding - Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) - Subject has known sensitivity to any of the products to be administered during dosing - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
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