Denosumab in patients with giant cell rich tumors of bone.

Phase 1

• Conditions: Aneurysmal bone cysts, giant cell granuloma, other giant cell rich lesions (primary bone, non-malignant); MedDRA version: 20.1Level: LLTClassification code 10018252Term: Giant cell granuloma peripheralSystem Organ Class: 100000004856; MedDRA version: 20.0Level: LLTClassification code 10004430Term: Benign osteoblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10008686Term: ChondroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10008733Term: Chondromyxoid fibromaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10002362Term: Aneurysmal bone cystSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-005244-42-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-25
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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 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 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