Melanoma Clinical Trial
Official title:
A Phase I Trial Of The Humanized Anti-GD2 Antibody (HU14.18K322A) In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma
Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are
considered difficult to treat and cure. For this study we are testing the use of a new
experimental (investigational) antibody called hu14.18K322A. GD2 is expressed on the surface
of most of these tumor types.
Two schedules of hu14.18K322A antibody will be evaluated in this study, (1) daily for four
consecutive days schedule every 28 days and (2) once weekly for 4 weeks schedule every 28
days. Approximately 25-40 participants will be required to define the maximum tolerated dose
for each schedule. Participants will continue on treatment for a maximum of 4 to 8 courses or
until one or more of the criteria for off-treatment are met.
SJGD2 is a Phase I dose finding study. The primary purpose of this phase I study is to
determine the maximum tolerated dose (MTD) and dose-limiting toxicity of the humanized
monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with refractory or
relapsed neuroblastoma or melanoma (Parts A and B) or osteosarcoma or Ewing sarcoma (Part C).
Initially, in Part A, one research participant will be treated at the lowest dose level of
hu14.18K322A antibody [2 mg/m^2 daily for 4 consecutive days every 28 days (1 course)], and
if no toxicity is observed then the next participant will be treated at the next dose level.
This is continued until the first instance of biological activity (in the form of grade 2
side effects) is observed and from that point on a traditional phase I study design will be
followed. A maximum of 4 courses may be given.
Part B: Hu14.18K322A antibody will be administered intravenously (IV) at a starting dose of
50 mg/m^2/dose weekly for 4 doses per course. One course is considered 28 days. A maximum of
8 courses may be given.
Part C: Hu14.18K322A antibody will be administered to 6 patients each with
refractory/recurrent osteosarcoma at a maximum tolerated dose (MTD) of 60 mg/m^2 daily for 4
consecutive days every 28 days (Part C1). A cohort of patients with refractory/recurrent
osteosarcoma or Ewing sarcoma will also be administered hu14.18K322A antibody at starting
dose of 40 mg/m^2/dose weekly for 4 doses per course (Part C2). Participants will continue on
treatment for a maximum of 8 courses.
Secondary objectives include:
1. Estimate the response rate, within the confines of a phase I study, to the humanized
anti-GD2 antibody, hu14.18K322A.
2. Evaluate the pharmacokinetics of hu14.18K322A.
3. Examine whether or not human anti-human antibodies (HAHA) develop in participants
receiving hu14.18K322A.
4. Assess the tolerability of the hu14.18K322A at the MTD of the daily x4 and the weekly
dosing in patients with refractory or recurrent osteosarcoma.
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