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

Completed · Phase 1

Conditions studied: Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

This phase I clinical trial is studying the side effects and best dose of IMC-A12 in treating young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal tumor or other solid tumors. Monoclonal antibodies, such as IMC-A12, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

Key facts

Study ID

NCT00609141

Run by

National Cancer Institute (NCI)

People needed

34

Starts

2008-01-01

Last updated by the study team

2014-06-19

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• COG Phase I Consortium — Arcadia, California, United States

Full record on ClinicalTrials.gov

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