NCT02470091

Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma

Phase 2 Study of Denosumab (NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 11 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as denosumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether denosumab therapy either increases the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to historical Children's Oncology Group (COG) experience or denosumab therapy produces an objective response rate greater than 5% (Cohort 1). II. To determine whether denosumab therapy increases the disease control rate at 12 months in patients with recurrent resected osteosarcoma as compared to historical COG experience (Cohort 2). SECONDARY OBJECTIVES: I. To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab in subjects with recurrent osteosarcoma. II. To describe the tolerability of denosumab in subjects with recurrent osteosarcoma. III. To report the disease control rate and objective response rate for patients with recurrent osteosarcoma limited to bone. IV. To investigate biological markers potentially associated with response to denosumab in patients with recurrent osteosarcoma. OUTLINE: Patients receive denosumab subcutaneously (SC) on day 1 (days 1, 8, and 15 of course 1 only). Treatment repeats every 4 weeks (28 days) for up to 24 months or 26 courses, whichever occurs first, in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 1 year.

Conditions

• Metastatic Osteosarcoma
• Recurrent Osteosarcoma
• Refractory Osteosarcoma
• Stage IV Osteosarcoma AJCC v7
• Stage IVA Osteosarcoma AJCC v7
• Stage IVB Osteosarcoma AJCC v7

Interventions

Type	Name	Description
BIOLOGICAL	Denosumab	Given SC
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2015-11-21
• Primary completion: 2019-12-31
• Completion: 2023-12-31
• First posted: 2015-06-12
• Last updated: 2024-01-22
• Results posted: 2021-02-21

Locations

141 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study