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Monoclonal Antibodies
Pharmacological Study for Osteosarcoma
Phase 2
Waitlist Available
Led By Katherine A Janeway
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years post-treatment
Awards & highlights
Study Summary
This trial is testing how well denosumab works in treating patients with recurrent or refractory osteosarcoma.
Who is the study for?
This trial is for patients with osteosarcoma that has returned or isn't responding to treatment. They must have had surgery to remove metastatic disease, not be on other cancer treatments, and have a certain level of physical ability (ECOG score 0-2). Patients need normal bilirubin levels, specific serum calcium levels, adequate kidney function, and no history of denosumab use or conditions affecting bone metabolism.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Denosumab, an immunotherapy monoclonal antibody in treating recurrent or refractory osteosarcoma. It includes laboratory biomarker analysis and pharmacological studies to see how well it helps the immune system attack cancer cells and prevent their growth.See study design
What are the potential side effects?
Denosumab may cause side effects such as weakened bones leading to fractures, low calcium levels in the blood (hypocalcemia), skin rash, nausea, fatigue. There's also a risk of serious infections since it affects the immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Control Rate (Cohort I)
Disease Control Rate (Cohort II)
Response Evaluation Criteria in Solid Tumors (RECIST) Response (Complete Response [CR] or Partial Response [PR] vs Not CR or PR) (Cohort I)
Secondary outcome measures
Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I)
Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort II)
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (denosumab)Experimental Treatment3 Interventions
Patients receive denosumab 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2017
Completed Phase 4
~12500
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,644 Total Patients Enrolled
30 Trials studying Osteosarcoma
7,798 Patients Enrolled for Osteosarcoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,097 Total Patients Enrolled
103 Trials studying Osteosarcoma
16,562 Patients Enrolled for Osteosarcoma
Katherine A JanewayPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
49 Total Patients Enrolled
1 Trials studying Osteosarcoma
49 Patients Enrolled for Osteosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have already taken denosumab before.You have certain medical conditions already present before the study starts.You have known allergies or sensitivities to any of the products used in the study, such as those derived from mammals, or calcium and vitamin D supplements.You have Paget's disease.You have had or currently have a condition called osteonecrosis of the jaw.You have a medical condition that is not stable and could affect your overall health, except for osteosarcoma. This includes conditions like unstable kidney dysfunction or heart failure."Complete resection" means that the surgeon removes all of the disease during the surgery. We do not need to check with imaging tests after the surgery to confirm this.You are currently taking bisphosphonates.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (denosumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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