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

This is an interventional treatment trial for Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Read More

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