NCT00831844

Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, NSC #742460) in Children With Relapsed/Refractory Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 7 Months – 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Rhabdomyosarcoma
• Adult Synovial Sarcoma
• Childhood Hepatoblastoma
• Childhood Synovial Sarcoma
• Previously Treated Childhood Rhabdomyosarcoma
• Recurrent Adrenocortical Carcinoma
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Childhood Liver Cancer
• Recurrent Childhood Rhabdomyosarcoma
• Recurrent Childhood Soft Tissue Sarcoma
• Recurrent Ewing Sarcoma/Peripheral Primitive
• Neuroectodermal Tumor
• Recurrent Neuroblastoma
• Recurrent Osteosarcoma
• Recurrent Retinoblastoma
• Recurrent Wilms Tumor and Other Childhood Kidney Tumors

Interventions

Type	Name	Description
BIOLOGICAL	cixutumumab	Given IV: Week 1 day 1, 9 mg/kg/dose over 1 hour. Week 2 Day 8, 9 mg/kg/dose over 1 hour. Week 3 Day 15, 9 mg/kg/dose over 1 hour. Week 4 Day 22, 9 mg/kg/dose over 1 hour.
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-04-01
• Completion: 2013-10-01
• First posted: 2009-01-29
• Last updated: 2015-03-30
• Results posted: 2015-03-30

Locations

105 sites across 3 countries: United States, Australia, Canada