Denosumab in patients with giant cell rich tumors of bone
- Conditions
- Aneurysmal bone cysts, giant cell granuloma, other giant cell rich lesions(primary bone, non-malignant)Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-005244-42-FR
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
The population will consist of patients with the following tumor types:
- Pathologically proven giant cell rich tumor
• ABC
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
- 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 study enrollment
- Patient is pregnant or breast feeding, or planning to become pregnant
within 5 months after the EOT visit
- Patient, or partner of patient, of child bearing potential is not willing to
use a highly effective method of contraception (Cf. appendix D - Child-bearing potential and effective 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method