TriangleNCT00396279 · CITED IN SOURCE DOCUMENTS
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2022-11-08
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants With Giant Cell Tumor Response
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Serum Denosumab Trough Concentrations
Number of Participants With Adverse Events (AEs)
Number of Participants With Anti-Denosumab Antibodies
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- 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.
- intervention Names
- Biological: Denosumab
- Dietary Supplement: Calcium/Vitamin D
- label
- Denosumab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Denosumab
- description
- Administered by subcutaneous injection
- name
- Denosumab
- other Names
- Xgeva®
- type
- BIOLOGICAL
- arm Group Labels
- Denosumab
- name
- Calcium/Vitamin D
- type
- DIETARY_SUPPLEMENT
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 37
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent \< 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.
- measure
- Percentage of Participants With Giant Cell Tumor Response
- time Frame
- From enrollment until 25 weeks
- secondary Outcomes
- description
- Urinary N-telopeptide (of type 1 collagen) corrected for urine creatinine (uNTX/Cr) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in uNTX/Cr was measured over time.
- measure
- Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
- time Frame
- Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81
- description
- Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.
- measure
- Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
- time Frame
- Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81
- description
- Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).
- measure
- Serum Denosumab Trough Concentrations
- time Frame
- Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.
- description
- An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.
- measure
- Number of Participants With Adverse Events (AEs)
- time Frame
- From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months
- description
- Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.
- measure
- Number of Participants With Anti-Denosumab Antibodies
- time Frame
- From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.
Full study description
- brief Summary
- To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
Source references
- references
- citation
- Branstetter DG, Nelson SD, Manivel JC, Blay JY, Chawla S, Thomas DM, Jun S, Jacobs I. Denosumab induces tumor reduction and bone formation in patients with giant-cell tumor of bone. Clin Cancer Res. 2012 Aug 15;18(16):4415-24. doi: 10.1158/1078-0432.CCR-12-0578. Epub 2012 Jun 18.
- pmid
- 22711702
- type
- BACKGROUND
- citation
- Thomas D, Henshaw R, Skubitz K, Chawla S, Staddon A, Blay JY, Roudier M, Smith J, Ye Z, Sohn W, Dansey R, Jun S. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol. 2010 Mar;11(3):275-80. doi: 10.1016/S1470-2045(10)70010-3. Epub 2010 Feb 10.
- pmid
- 20149736
- type
- BACKGROUND
- citation
- Engellau J, Seeger L, Grimer R, Henshaw R, Gelderblom H, Choy E, Chawla S, Reichardt P, O'Neal M, Feng A, Jacobs I, Roberts ZJ, Braun A, Bach BA. Assessment of denosumab treatment effects and imaging response in patients with giant cell tumor of bone. World J Surg Oncol. 2018 Sep 19;16(1):191. doi: 10.1186/s12957-018-1478-3.
- pmid
- 30231890
- type
- DERIVED
- see Also Links
- label
- AmgenTrials clinical trials website
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Preserved source evidence · Not medical advice