Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
Condition: 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
MeSH terms: Neoplasms; Sarcoma; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Wilms Tumor; Retinoblastoma; Rhabdomyosarcoma, Embryonal; Sarcoma, Synovial; Adrenocortical Carcinoma; Hepatoblastoma; Recurrence
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): cixutumumab; laboratory biomarker analysis
Intervention type(s): Biological; Other
Intervention description(s): 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.; Correlative studies
Other intervention name(s): anti-IGF-1R recombinant monoclonal antibody IMC-A12; IMC-A12
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment