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Humanized Monoclonal Antibody 3F8 and Sargramostim in Treating Patients with Recurrent Osteosarcoma

Trial Status: Active

This phase II trial studies how well humanized monoclonal antibody 3F8 (Hu3F8) and sargramostim work in treating patients with bone cancer (osteosarcoma) that has come back (recurrent). Humanized monoclonal antibody 3F8 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the number of granulocytes (kinds of white blood cells that are able to kill cancer cells). Sargramostim increases the number of other kinds of white blood cells that may help attack tumor cells. Sargramostim may also make humanized monoclonal antibody 3F8 more effective against osteosarcoma. Giving humanized monoclonal antibody 3F8 together with sargramostim may be an effective treatment for patients with osteosarcoma.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

California

Los Angeles
Children's Hospital Los Angeles
Status: ACTIVE
Contact: Fariba Navid
Phone: 323-660-2450

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Filemon Sorillo Dela Cruz
Phone: 646-888-2275

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Douglas J. Harrison
Phone: 713-456-5995

PRIMARY OBJECTIVE:

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).

SECONDARY OBJECTIVES:

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.

OUTLINE:

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

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Filemon Sorillo Dela Cruz

  • Primary ID 15-096
  • Secondary IDs NCI-2015-01423
  • Clinicaltrials.gov ID NCT02502786