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Dinutuximab for Osteosarcoma
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.
- Osteosarcoma
- Lung Cancer
- Bone Sarcoma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- The patient must have a tumor specimen that is large enough to be submitted for testing.Patients must have a performance status corresponding to scores of 0, 1 or 2 on the Eastern Cooperative Oncology Group scale; use Karnofsky for patients > 16 years old and Lansky for patients =< 16 years old.that is an anti-neoplastic agent, such as an interferon, a tumor necrosis factor, or a chemotherapeutic agent
Biologic agents that are anti-neoplastic agents, such as interferons, tumor necrosis factors, and chemotherapeutic agents, should not be given to a patient for at least 7 days after the completion of therapy.People who are receiving myelosuppressive anti-cancer therapy cannot participate in this studyWe are looking for people who have had surgery to remove any possible cancerous tumors in their lungs within the last 4 weeks.If you have surgery related changes such as atelectasis seen on the post-operative computed tomography (CT) scan, you will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected
- Group 1: Treatment (sargramostim and dinutuximab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
Who else is applying?
What portion of applicants met pre-screening criteria?
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