UnknownPhase 2

Denosumab in Subjects With Giant Cell Rich Tumors of Bone

France, Italy, Netherlands60 participantsStarted 2018-06-18

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy (proportion of subjects who do not require surgery during the study)

Timeframe: Continuous monitoring until surgery of max treatment duration of 3 years.

Efficacy (proportion of subjects undergoing the planned versus performed type of surgery during the study)

Timeframe: Continuous monitoring until surgery of max treatment duration of 3 years.

Efficacy (Radiological response)

Timeframe: Imaging to be performed every 3 months. Up to maximum duration of treatment of 3 years.

Efficacy (disease progression based on clinical disease assessment)

Timeframe: Clinical disease assessment performed every 4 weeks. Up to maximum duration of treatment of 3 years.

Efficacy (combined pain scores)

Timeframe: Questionnaires on pain to be performed every 4 weeks. Up to maximum duration of treatment of 3 years.

Trial details

NCT IDNCT03605199

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06

Contact for this trial

A Lipplaa, MD

a.lipplaa@lumc.nl

View on ClinicalTrials.gov More Aneurysmal Bone Cysts trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Efficacy (proportion of subjects who do not require surgery during the study)

Timeframe: Continuous monitoring until surgery of max treatment duration of 3 years.

Efficacy (proportion of subjects undergoing the planned versus performed type of surgery during the study)

Timeframe: Continuous monitoring until surgery of max treatment duration of 3 years.

Efficacy (Radiological response)

Timeframe: Imaging to be performed every 3 months. Up to maximum duration of treatment of 3 years.

Efficacy (disease progression based on clinical disease assessment)

Timeframe: Clinical disease assessment performed every 4 weeks. Up to maximum duration of treatment of 3 years.

Efficacy (combined pain scores)

Timeframe: Questionnaires on pain to be performed every 4 weeks. Up to maximum duration of treatment of 3 years.