AZD2171 to Treat Children and Adolescents With Solid Tumors or Acute Myelogenous Leukemia

Summary

Background: * AZD2171 is an experimental drug that may slow the growth of cancers by blocking angiogenesis (formation of new blood vessels). * Cancer growth is dependent on angiogenesis for nutrition. * Inhibiting angiogenesis is a new approach to cancer therapy. Objectives: * To determine the side effects of AZD2171 in children and adolescents with cancer. * To determine the highest dose of AZD2171 that can safely be given to children and adolescents with cancer. * To study how the body handles AZD2171. * To determine the effects of AZD2171 on various factors related to angiogenesis. * To determine if AZD2171 can inhibit cancer growth in children and adolescents. Eligibility: -Children and adolescents 2-18 years of age with treatment-resistant solid tumor cancers or acute myelogenous leukemia. Design: * About 40 patients may be included in the study. * AZD2171 is given by mouth in treatment cycles of once a day for 28 days. Treatment may continue unless the cancer worsens or unacceptable side effects develop. * Patients have periodic physical examinations, blood and urine tests and imaging tests (CT, X-rays, MRI) to evaluate disease throughout the course of treatment. Additional blood tests are done to study how the body handles AZD2171, to look for proteins that stimulate angiogenesis, to determine if certain blood vessel cells are affected by AZD2171, and for other research purposes. * Biopsy tissue (when available) is examined for the receptor for new blood vessel formation.

Timeline

Start

2006-05-01

Primary completion

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Completion

2011-10-06

Publications

• Background Folkman J. What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst. 1990 Jan 3;82(1):4-6. doi: 10.1093/jnci/82.1.4. No abstract available.
• Background Arap W, Pasqualini R, Ruoslahti E. Cancer treatment by targeted drug delivery to tumor vasculature in a mouse model. Science. 1998 Jan 16;279(5349):377-80. doi: 10.1126/science.279.5349.377.
• Background Konerding MA, Malkusch W, Klapthor B, van Ackern C, Fait E, Hill SA, Parkins C, Chaplin DJ, Presta M, Denekamp J. Evidence for characteristic vascular patterns in solid tumours: quantitative studies using corrosion casts. Br J Cancer. 1999 May;80(5-6):724-32. doi: 10.1038/sj.bjc.6690416.
• Fox E, Aplenc R, Bagatell R, Chuk MK, Dombi E, Goodspeed W, Goodwin A, Kromplewski M, Jayaprakash N, Marotti M, Brown KH, Wenrich B, Adamson PC, Widemann BC, Balis FM. A phase 1 trial and pharmacokinetic study of cediranib, an orally bioavailable pan-vascular endothelial growth factor receptor inhibitor, in children and adolescents with refractory solid tumors. J Clin Oncol. 2010 Dec 10;28(35):5174-81. doi: 10.1200/JCO.2010.30.9674. Epub 2010 Nov 8.

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