Recurrent Neuroblastoma Clinical Trial
Official title:
A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, NSC #742460) in Children With Relapsed/Refractory Solid Tumors
This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PRIMARY OBJECTIVES:
I. To determine the response rate to IMC-A12 (cixutumumab) administered in various strata of
recurrent/refractory malignant solid tumors in childhood and young adulthood.
II. To further define and describe the toxicities of IMC-A12. III. To further characterize
the pharmacokinetics of IMC-A12.
SECONDARY OBJECTIVES:
I. To examine the relationship between tumor expression of insulin-like growth factor
(IGF)-I, IGF-II, and IGF-I receptor (IR) and response to IMC-A12.
II. To determine the human anti-human antibody (HAHA) response after treatment with IMC-A12.
III. To further evaluate the effect of IMC-A12 on circulating levels of proteins involved in
linear growth and glucose homeostasis, including IGF-I, IGF-II, IGF-BP3, growth hormone,
insulin, and C-peptide.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type.
Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, 15, and 22.
Treatment repeats every 28 days for up to 24 courses in the absence of disease progression
or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative laboratory studies.
Samples are analyzed for IGF-I, IGF-II, IGF-BP3, growth hormone, insulin, and C-peptide
levels and for immunogenicity.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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