Denosumab in Subjects With Giant Cell Rich Tumors of Bone

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborator: Amgen
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Pathologically proven giant cell rich tumor:

• Aneurysmal bone cysts (ABC)

• Giant cell granuloma (GCG)

• Other giant cell rich lesions (primary bone, non-malignant, pathology and radiology to be reviewed during multidisciplinary meeting LUMC)

• Patients with surgically unsalvageable disease (e.g., sacral, spinal giant cell rich tumors, or multiple lesions including pulmonary metastases) OR patients whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity

• Measurable evidence of active disease within 1 year before study enrollment

• Albumin-adjusted serum calcium level ≥ 2.0 mmol/L (8.0 mg/dL)

• Aged 18 years and up and skeletally mature

• ECOG performance status 0, 1 or 2

• Written signed informed consent

Exclusion Criteria:

• Known or suspected current diagnosis of classic GCTB

• Known or suspected current diagnosis of underlying malignancy including but not limited to high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma

• Known or suspected current diagnosis of brown cell tumor of hyperparathyroidism, Paget's disease or cherubism

• Known or suspected current diagnosis of primary soft tissue tumor with invasion of the bone

• Known diagnosis of other malignancy within the past 5 years (patients with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)

• Previous treatment with denosumab (with the exception of patients eligible for re-treatment with denosumab after completing this study)

• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw

• Active dental or jaw condition which requires oral surgery, including tooth extraction

• Non-healed dental/oral surgery

• Planned invasive dental procedure for the course of the study

• Known hypersensitivity to denosumab

• Known hypersensitivity to products to be administered during the study (calcium and/or vitamin D)

• Currently receiving other specific treatment for giant cell rich tumors of bone (e.g., radiation, chemotherapy or embolization)

• Concurrent bisphosphonate treatment

• Major surgery less than 4 weeks prior to start of treatment

• Treatment with other investigational device or drug 30 days prior to study enrollment

• Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment

• Patient is pregnant or breast feeding, or planning to become pregnant within 5 months after the EOT visit

• Female patient of child bearing potential is not willing to use a highly effective method of contraception during treatment and for 5 months after the EOT visit

• Patient has any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures