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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-10

Study Completion Date

2011-02-01

Brief Summary

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

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Detailed Description

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Conditions

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GCT Giant Cell Tumor of Bone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denosumab

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.

Group Type EXPERIMENTAL

Denosumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Calcium/Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Denosumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Calcium/Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Xgeva®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No