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

Completed · Phase 1

Conditions studied: Refractory or Recurrent Solid Tumors, Acute Myelogenous Leukemia

In brief

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.

Key facts

Study ID: NCT00321581
Run by: National Cancer Institute (NCI)
People needed: 18
Starts: 2006-05-01
Expected to finish: 2011-10-06
Last updated by the study team: 2019-11-21

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients with primary brain tumors.
Patients with a history of congenitally prolonged QTc, or history of arrhythmia (multifocal premature ventricular contractions, bigeminy,trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation, left bundle block) that is symptomatic or requires treatment (except for controlled atrial fibrillation).
Patients receiving medication for treatment of hypertension or patients with a diastolic blood pressure 5mmHg greater than the 95% for gender and age on 3 measurements using an appropriate size cuff are excluded.
Patients who have had major surgery within the past 3 months. Patients having minor surgery (e.g., central line placement) within the past 2 weeks.
Patients with history of arterial or venous thrombosis within the prior 3 months.
Patients requiring systemic full dose anticoagulation with systemic thrombolytics, heparin, coumadin, or low molecular weight heparin or other anticoagulants for therapy of active thrombosis within the prior 3 months.
Patients experiencing significant hemorrhage (hemoptysis, melena, or hematemesis) within the past 2 weeks.
Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal, gastrointestinal or other organ dysfunction, which in the judgment of the principal investigator, protocol chairperson or associate investigator would compromise the patient's ability to tolerate the investigational agent or are likely to interfere with the study procedures or endpoints.
Patients with active GVHD are excluded.
Pregnant or breastfeeding females are excluded because Cediranib may be harmful to the developing fetus or nursing child.
Patients currently receiving other investigational agents.
Patients previously known to be Hepatitis B, Hepatitis C, or HIV infected because of the unknown interaction of Cediranib with antiviral therapy.
Patients or first degree relatives of persons that are involved in the planning and conduct of this trial are excluded.
Patients who have previously received Cediranib.
Patients who are allergic to Cediranib or its excipients (mannitol, sodium starch glycollate and magnesium stearate).

Where it is running

Childrens Hospital, Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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