Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT02502786|
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : December 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Osteosarcoma||Biological: humanized anti-GD2 antibody Drug: GM-CSF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF
One cycle consists of treatment with hu3F8 at a dose of 2.4mg/kg/dose for 3 days (day 1, 3, and 5) in the presence of subcutaneous (sc) GM-CSF (day -4 through 5). These 3 doses of hu3F8 and 10 days of GM-CSF constitute a treatment cycle. Cycles are repeated at ~2-4 week intervals between first days of hu3F8, through 5 cycles. A maximum of 5 cycles will be administered on protocol.
Biological: humanized anti-GD2 antibody
Other Name: hu3F8
- event free survival (EFS) [ Time Frame: 12 months ]EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy.
- time to recurrence [ Time Frame: 12 months ]Time to recurrence will be estimated using Kaplan-Meier methods. Very few patients are expected to die without relapse (<5%). Recurrence is defined as the radiographic presence of any new lesion that is not attributable to differences in scanning techniques, change in imaging modality or findings thought to represent something other than osteosarcoma, or if a biopsy is performed which shows osteosarcoma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502786
|Contact: Filemon Dela Cruz, MD||646-888-2275|
|Contact: Stephen Roberts, MD||212-639-4034|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Filemon Dela Cruz, MD 646-888-2275|
|Contact: Stephen Roberts, MD 212-639-4034|
|Principal Investigator: Filemon Dela Cruz, MD|
|Principal Investigator:||Filemon Dela Cruz, MD||Memorial Sloan Kettering Cancer Center|