IMC-A12 in Treating Young Patients With Relapsed or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor or Other Solid Tumor

Inclusion Criteria

• •Histologically confirmed solid tumor
• •* Relapsed or refractory disease
• •* No central nervous system (CNS) tumor or lymphoma
• •* Histological confirmation may have been made at original diagnosis or at relapse
• •Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
• •Measurable or evaluable disease
• •Patients with Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET) must have tissue blocks or slides available
• •* Study chair must be notified if tissue blocks or slides are not available
• •Karnofsky performance status (PS) ≥ 50% (patients \> 10 years of age) and Lansky (PS) ≥ 50% (patients ≤ 10 years of age)
• •* Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• •Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
• •* 1 to \< 2 years (males and females 0.6 mg/dL)
• •* 2 to \< 6 years (males and females 0.8 mg/dL)
• •* 6 to \< 10 years (males and females 1.0 mg/dL)
• •* 10 to \< 13 years (males and females 1.2 mg/dL)
• •* 13 to \< 16 years (males 1.5 mg/dL and females 1.4 mg/dL)
• •* ≥ 16 years (males 1.7 mg/dL and females 1.4 mg/dL)
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
• •SGPT (ALT) ≤ 110 μ/L (for the purpose of this study, the ULN for SGPT is 45 μ/L)
• •Serum albumin ≥ 2 g/dL
• •Patients with known bone marrow metastatic disease will be eligible for study but not evaluable for hematologic toxicity
• •* Patients must not be known to be refractory to red cell or platelet transfusion
• •Patients with solid tumors without bone marrow involvement must meet the following criteria:
• •* Peripheral absolute neutrophil count ≥ 1,000/μL
• •* Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
• •* Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• •No uncontrolled infection
• •No known type I or type II diabetes mellitus
• •Able to comply with the safety monitoring requirements of the study, in the opinion of the investigator
• •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12
• •Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• •At least 7 days since prior and no concurrent hematopoietic growth factors
• •* Growth factors that support platelet or white cell number or function can only be administered for culture-proven bacteremia or invasive fungal infection
• •At least 7 days since prior and no concurrent biologic antineoplastic agents
• •At least 6 weeks since prior monoclonal antibodies
• •At least 3 months since prior total body irradiation (TBI), craniospinal external radiotherapy (XRT), or ≥ 50% radiotherapy to the pelvis
• •At least 2 weeks since prior local XRT (small port)
• •At least 6 weeks since other prior substantial bone marrow radiotherapy
• •More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
• •More than 7 days since prior and no concurrent systemic corticosteroids
• •Prior stem cell transplant or rescue allowed provided there has been no evidence of active graft-versus-host-disease within the past 2 months
• •No prior monoclonal antibody therapy targeting the IGF-IR
• •No concurrent chemotherapy, radiotherapy, or immunotherapy
• •No concurrent anticancer agents
• •No concurrent insulin or growth hormone therapy
• •No other concurrent investigational drugs