Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

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