Study Summary
This trial is testing an antibody and drug combo to see if it can keep cancer in remission or prevent it from coming back.
- Osteosarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 12 months
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF
1 of 1
Experimental Treatment
46 Total Participants · 1 Treatment Group
Primary Treatment: GM-CSF · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 13 - 40 · All Participants · 14 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.
- Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
- 2015. "Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02502786.
Frequently Asked Questions
Is this investigation a groundbreaking case of its kind?
"GM-CSF has been extensively researched, with the first trials sponsored by Y-mAbs Therapeutics in 2011. Following successful Phase 1 clinical testing involving 68 patients, several live studies have since followed across 8 cities and 9 countries." - Anonymous Online Contributor
Does this experiment admit geriatric individuals?
"According to the enrollment requirements, patients must be between 13 months and 40 years old. Meanwhile, there are 233 studies available for minors while 958 clinical trials pertain to seniors 65 or older." - Anonymous Online Contributor
How many subjects have been enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov documents show that this medical study, initially posted on the 1st of July 2015, is recruiting patients currently. This clinical trial aims to enlist 46 individuals from 3 different sites." - Anonymous Online Contributor
Is there still an opportunity to join this experiment?
"Based on the data available from clinicaltrials.gov, this medical study is presently enrolling patients. The trial was made public on July 1st 2015, and its details were last updated in November 17th 2022." - Anonymous Online Contributor
What research has been conducted in relation to the use of GM-CSF?
"The initial investigation of GM-CSF took place in 2011 at Memorial Sloan Kettering Cancer Center. Thus far, 41 studies have been concluded with 7 trials ongoing as of now; many of these are hosted by medical centres situated in Houston, Texas." - Anonymous Online Contributor
What potential risks does GM-CSF pose to those who utilize it?
"This Phase 2 trial has evidence to suggest that GM-CSF is safe, resulting in an estimated score of 2 on our Power scale. Unfortunately, there is not yet any data supporting its efficacy." - Anonymous Online Contributor