Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone

Amgen

Status and phase: Completed; Phase 2

Conditions: GCT; Giant Cell Tumor of Bone

Treatments: Dietary Supplement: Calcium/Vitamin D; Biological: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396279

20040215

Details and patient eligibility

About

To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Denosumab

Experimental group

Description:

Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg doses on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.

Treatment:

Biological: Denosumab

Dietary Supplement: Calcium/Vitamin D