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Monoclonal Antibodies

Dinutuximab for Osteosarcoma

Phase 2
Waitlist Available
Led By Pooja Hingorani
Research Sponsored by National Cancer Institute (NCI)
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 12 months after study enrollment
Awards & highlights

Study Summary

This trial gives dinutuximab, a cancer-fighting antibody, with sargramostim to recurrent osteosarcoma patients. Sargramostim helps the body produce more white blood cells, which fight infection.

Eligible Conditions
  • Osteosarcoma
  • Lung Cancer
  • Bone Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control
Secondary outcome measures
Area Under the Curve (AUC)0 to Infinity of Serum Dinutuximab
Maximum of Concentration (Cmax) of the Serum Concentration Dinutuximab
Number of Cycles Where an Unacceptable Toxicity as Defined in the Protocol Using The National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 Was Observed
+2 more
Other outcome measures
Banking of Tumor Samples (Optional)
Change in Circulating Ligand B7-H6 Levels
Circulating Tumor Deoxyribonucleic Acid Detection
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sargramostim and dinutuximab)Experimental Treatment4 Interventions
Patients receive sargramostim SC QD on days 1-14 and dinutuximab IV over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dinutuximab
2009
Completed Phase 3
~710
Sargramostim
2008
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,626 Total Patients Enrolled
103 Trials studying Osteosarcoma
16,577 Patients Enrolled for Osteosarcoma
Pooja HingoraniPrincipal InvestigatorChildren's Oncology Group

Media Library

Dinutuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02484443 — Phase 2
Osteosarcoma Research Study Groups: Treatment (sargramostim and dinutuximab)
Osteosarcoma Clinical Trial 2023: Dinutuximab Highlights & Side Effects. Trial Name: NCT02484443 — Phase 2
Dinutuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02484443 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions can Dinutuximab be used to address?

"Dinutuximab is commonly prescribed to address severe infections, but has also been seen as a viable option for the treatment of lymphoma, Hodgkin's disease, and acute myelocytic leukemia. In some cases it can be employed in bone marrow transplantation procedures."

Answered by AI

Have there been any other investigations into the efficacy of Dinutuximab?

"At the moment, 53 clinical studies are exploring Dinutuximab's potential. Of those trials, 7 have advanced to Phase 3 and there are 2109 sites across America conducting research into this medication. The epicentre of these investigations is Seattle, Washington."

Answered by AI

At what geographic sites can this research be accessed?

"This clinical trial is being conducted in 103 different healthcare institutions, with particular focus on Ascension Saint Vincent Indianapolis Hospital in Indiana, Centre Hospitalier Universitaire de Quebec in Florida and Johns Hopkins All Children's Hospital in Pennsylvania."

Answered by AI

Has Dinutuximab been granted authorization by the FDA?

"There is limited evidence stemming from Dinutuximab's Phase 2 clinical trial that suggests a level of safety, thus earning it a score of 2."

Answered by AI

How many participants are collaborating in this research project?

"Unfortunately, this trial is no longer accepting candidates. It was initially posted on November 30th 2015 and its most recent update occurred on the 16th of November 2022. For those searching for other studies related to osteosarcoma there are 3367 open trials while 53 others now recruiting participants involve Dinutuximab treatments."

Answered by AI

Is enrollment for this trial currently available to the public?

"Unfortunately, this study is not in the process of seeking participants. Initial posting was on November 30th 2015 and it has not been updated since November 16th 2022. If you are searching for trials related to osteosarcoma or Dinutuximab, there are presently 3367 and 53 studies actively recruiting patients respectively."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Apr 2025