This phase I trial studies the side effects and best dose of humanized monoclonal antibody 3F8 in treating patients with high-risk neuroblastoma or ganglioside (GD)2-positive tumors that do not respond to treatment or have come back. Monoclonal antibodies, such as humanized monoclonal antibody 3F8, may interfere with the ability of tumor cells to grow and spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01419834.
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dosage of humanized monoclonal antibody 3F8 (hu3F8).
SECONDARY OBJECTIVES:
I. To study the pharmacokinetics of hu3F8.
II. To assess activity of hu3F8 against neuroblastoma (NB) and other GD2-positive tumors.
III. To quantitate pain during hu3F8 treatment.
OUTLINE: This is a dose-escalation study.
Patients receive humanized monoclonal antibody 3F8 intravenously (IV) over 30 minutes on either days 1 and 8 or days 1, 3 and 5. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. (After course 4, treatment can be given approximately every 8 weeks at the discretion of the Principal Investigator). Patients who complete the 12 courses of treatment with no disease progression and if clinically indicated are eligible to receive additional courses of treatment for up to 2 years from the start of treatment to a maximum of 20 courses.
After completion of study treatment, patients are followed up every 3 months for up to 2 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorEllen M. Basu
