Humanized Monoclonal Antibody 3F8 and Sargramostim in Treating Patients with Recurrent Osteosarcoma
- Patients must have recurrent OS; OS must be verified by histopathology review by the site's Department of Pathology; (patients registered at Memorial Sloan-Kettering [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
- 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
- Absolute neutrophil count >= 500/ul
- Absolute lymphocyte count >= 500/ul
- Platelet count >= 50,000/ul (transfusion independent)
- 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)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) of =< 3 times upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) of =< 3 times upper limit of normal
- Serum creatinine of =< 1.5 times upper limit of normal
- Shortening fraction of >= 28% or an ejection fraction >= 50%
- No evidence of dyspnea at rest and no history of exercise intolerance
- Eastern Cooperative Oncology Group (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 human anti-human antibody (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
I. To evaluate event free survival (EFS) at 12 months after study enrollment in patients with pulmonary-only recurrent osteosarcoma (OS) treated with Hu3F8 (naxitamab) when combined with granulocyte-macrophage colony stimulating factor (GM-CSF).
I. To evaluate time to recurrence in patients with recurrent OS treated with Hu3F8 and GM-CSF.
II. To evaluate overall survival in patients with recurrent OS treated with Hu3F8 and GM-CSF.
III. To describe the toxicity associated with Hu3F8 and GM-CSF in patients with recurrent OS.
IV. To estimate EFS at 12 months in patients with extra-pulmonary recurrent OS.
V. To characterize the pharmacokinetics of naxitamab in patients with recurrent osteosarcoma.
Patients receive sargramostim subcutaneously (SC) on days -4 to 5 and naxitamab intravenously (IV) over 30-90 minutes on days 1, 3, and 5. Treatment repeats every 3-5 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.
Trial Phase Phase II
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
Filemon Sorillo Dela Cruz
- Primary ID 15-096
- Secondary IDs NCI-2015-01423
- Clinicaltrials.gov ID NCT02502786