Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumo… (NCT00396279) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
37 participantsStarted 2006-07-10
Plain-language summary
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
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:
* Adults, 18 years and older
* Histologically confirmed and measurable giant cell tumor (GCT)
* Recurrent GCT confirmed by radiology or unresectable GCT
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria:
* Pateints for whom surgery to the affected limb/area is planned within 27 days after receiving 1st dose of denosumab
* Radiation to affected region within 28 days before enrollment to study
* Known diagnosis of osteosarcoma or brown tumor of bone
* Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ
* Concurrent treatment with bisphosphonates, calcitonin, or interferon.
Other criteria also apply.
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
1
Percentage of Participants With Giant Cell Tumor Response