Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02502786|
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : December 23, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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 :||46 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 2023|
|Estimated Study Completion Date :||July 2023|
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. If elevations of amylase and/or lipase (>Grade 1) or clinical signs suggestive of pancreatitis (e.g. upper abdominal pain) occurs, naxitamab and GM-CSF doses should be held until improvement of toxicity to ≤Grade 1 if laboratory elevations and/or pancreatitis is possibly related to either naxitamab or GM-CSF.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||13 Months to 40 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.)
- Patients must be in a ≥2nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry.
- Patients must be ≥ 1 year of age and ≤ to 40 years of age at the time of enrollment.
- Prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery.
NOTE: Minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment)
Adequate hematopoietic function defined as:
- Absolute neutrophil count ≥ 500/ul
- Absolute lymphocyte count ≥ 500/ul
- Platelet count ≥ 50,000/ul (transfusion independent)
Adequate hepatic function as defined by:
- Total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is ≤ 3 times upper limit of normal).
- AST (SGOT) of ≤ 3 times upper limit of normal
- ALT (SGPT) of ≤ 3 times upper limit of normal
- Adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limit of normal
- Adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection fraction ≥ 50%
- Adequate pulmonary function as defined by no evidence of dyspnea at rest at no history of exercise intolerance
- Adequate performance status as defined by ECOG score of ≤ 2 or Karnofsky/Lansky score ≥ 50%
- Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with Hu3F8 is NOT allowed), but HAHA antibody titer must be negative
- Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
- Signed informed consent indicating awareness of the investigational nature of this program
- Patients with OS in first complete remission.
- Presence of overt metastatic disease at any site.
- Active life-threatening infection.
- Pregnant women or women who are breast-feeding.
- Inability to comply with protocol requirements.
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: Michael Kinnaman, MD||212-639-5952|
|United States, California|
|Children's Hospital of Los Angeles (Data Collection Only)||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Fariba Navid, MD 323-660-2450|
|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: Michael Kinnaman, MD 212-639-5952|
|Principal Investigator: Filemon Dela Cruz, MD|
|United States, Texas|
|MD ANDERSON CANCER CENTER (Data Collection Only)||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Douglas Harrison, MD 713-456-5995|
|Principal Investigator:||Filemon Dela Cruz, MD||Memorial Sloan Kettering Cancer Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Memorial Sloan Kettering Cancer Center|
|Other Study ID Numbers:||
|First Posted:||July 20, 2015 Key Record Dates|
|Last Update Posted:||December 23, 2022|
|Last Verified:||December 2022|
Humanized Monoclonal Antibody 3F8 (Hu3F8)
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Physiological Effects of Drugs