Refractory Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase 1/2 Trial of VX15/2503 in Children, Adolescents, or Young Adults With Recurrent or Relapsed Solid Tumors
This phase I/II trial studies the side effects and best dose of anti-SEMA4D monoclonal antibody VX15/2503 (VX15/2503) and to see how well it works in treating younger patients with solid tumors that have come back after treatment, or do not respond to treatment. Monoclonal antibodies, such as VX15/2503, may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of VX15/2503
administered as an intravenous infusion every 14 days to children with recurrent or
refractory solid tumors. (Part A) II. To define and describe the toxicities of VX15/2503
administered on this schedule. (Parts A-B) III. To characterize the pharmacokinetics of
VX15/2503 in children with recurrent or refractory cancer. (Parts A-B) IV. To preliminarily
define the antitumor activity of VX15/2503 for the treatment of relapsed or refractory
osteosarcoma. (Part B) V. To determine if VX15/2503 either improves the disease control rate
at 4 months in patients with recurrent measurable osteosarcoma or produces an objective
response rate in patients with relapsed or refractory osteosarcoma.
SECONDARY OBJECTIVES:
I. To assess the pharmacodynamics of VX15/2503 through VX15/2503 saturation of T-lymphocytes.
II. To assess the immunogenicity of VX15/2503 in pediatric patients with recurrent or
refractory cancer.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive VX15/2503 intravenously (IV) over 60 minutes on days 1 and 15. Treatment
repeats every 28 days for 13 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up periodically.
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