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

NCT00321581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-11-21

No results posted yet for this study

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.

Conditions

  • Refractory or Recurrent Solid Tumors
  • Acute Myelogenous Leukemia

Interventions

DRUG

Cediranib, AZD2171, RECENTIN

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Brigitte C Widemann, M.D. · National Cancer Institute (NCI)

Study Design

Purpose
TREATMENT

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-01
Completion
2011-10-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00321581 on ClinicalTrials.gov