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Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma

NCT02470091 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-01-22

Study results available
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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.

Conditions

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

Interventions

BIOLOGICAL

Denosumab

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Katherine A Janeway · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-21
Primary Completion
2019-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470091 on ClinicalTrials.gov