Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Y-mAbs Therapeutics | INDUSTRY |
The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8) and a drug called GM-CSF have on the patient and whether it can keep the patient in remission longer and/or prevent recurrence of the disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| humanized anti-GD2 antibody | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| event free survival (EFS) | EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| time to recurrence | 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. |
Not provided
Inclusion Criteria:
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:
Adequate hepatic function as defined by:
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Filemon Dela Cruz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles (Data Collection Only) | Los Angeles | California | 90027 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31401903 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GM-CSF |
| Drug |
|
| 12 months |
| Memorial Sloan Kettering Cancer Center |
| New York |
| New York |
| 10065 |
| United States |
| MD ANDERSON CANCER CENTER (Data Collection Only) | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654310 | humanized 3F8 anti-GD2 monoclonal antibody |
| C000718263 | naxitamab |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided