Ensayos clínicos

Inclusion Criteria:

• Histologically confirmed malignant solid tumor, including the following:

  • Osteosarcoma
  • Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Rhabdomyosarcoma
  • Neuroblastoma
  • Wilms tumor
  • Synovial sarcoma
  • Hepatoblastoma
  • Adrenocortical carcinoma
  • Retinoblastoma
• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists

• Radiographically measurable disease*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by MRI or CT scan or ≥ 10 mm by spiral CT scan

  • The following are not considered measurable disease:

    • Ascites, pleural effusions, or other malignant fluid collections
    • Bone marrow infiltration by tumor
    • Lesions detected only by non-MIBG nuclear medicine studies (e.g., bone scan)
    • Previously irradiated lesions that have not demonstrated clear progression post-radiotherapy
• No known Central Nervous System (CNS) metastases unless they were treated by surgery or radiotherapy AND are stable with no recurrent lesions for ≥ 3 months
• Lansky or Karnofsky performance status (PS) 50-100% OR Eastern Cooperative Oncology Group (ECOG) PS 0-2
• Absolute neutrophil count (ANC) ≥ 1,000/mm³ (> 250/mm³ for patients with neuroblastoma)
• Platelet count ≥ 75,000/mm³ (> 25,000/mm³ for patients with neuroblastoma) (transfusion independent)
• Hemoglobin ≥ 8.0 g/dL (≥ 7.5 g/dL for patients with neuroblastoma) (RBC transfusion allowed)

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine normal based on age/gender as follows:

  • ≤ 0.4 mg/dL (for patients 1 to 5 months of age)
  • ≤ 0.5 mg/dL (for patients 6 to 11 months of age)
  • ≤ 0.6 mg/dL (for patients 1 year of age)
  • ≤ 0.8 mg/dL (for patients 2 to 5 years of age)
  • ≤ 1 mg/dL (for patients 6 to 9 years of age)
  • ≤ 1.2 mg/dL (for patients 10 to 12 years of age)
  • ≤ 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
  • ≤ 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
• Total bilirubin ≤ 1.5 times upper limit of normal for age
• Alanine transaminase (ALT) ≤ 110 U/L
• Serum albumin ≥ 2 g/dL
• Blood glucose normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Able to comply with safety monitoring requirements of study
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug
• No uncontrolled infection
• No known type I or II diabetes mellitus
• Recovered from prior chemotherapy, immunotherapy, or radiotherapy
• More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
• At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim)
• At least 6 weeks since prior monoclonal antibody therapy
• At least 7 days since other prior antineoplastic biologic agents
• No prior monoclonal antibody targeting the IGF-IR
• No prior small molecule kinase inhibitors of IGF-IR
• At least 2 weeks since prior local palliative (small port) radiotherapy
• At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
• At least 6 weeks since other prior substantial bone marrow radiotherapy

• At least 2 months since prior stem cell transplantation

  • No evidence of graft-versus-host disease

• Concurrent corticosteroids allowed provided dose is stable or decreasing over the past 7 days

  • Intermittent use of corticosteroids to manage infusional reactions allowed
• No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
• No other concurrent investigational agents
• No concurrent insulin or growth hormone therapy