Trial Information

Summary: COG A003: Phase I trial and pharmacokinetic study of arsenic trioxide in pediatric patients with refractory leukemia or lymphoma

You have/your child has been asked to participate in this research study because you have/your child has been diagnosed with refractory leukemia or lymphoma. Refractory means that your/your child's leukemia or lymphoma is not responding to standard treatment. Since your/your child's leukemia or lymphoma is resistant to standard treatment, you are/your child is eligible to receive arsenic trioxide. Arsenic trioxide, a naturally occurring compound, is an experimental drug that has been reported to have an anti-disease effect in laboratory studies.

The primary goals of this study are:

1> to determine the side effects of arsenic trioxide in children and adolescents with refractory leukemia or lymphoma,
2> to determine the highest dose of arsenic trioxide that can be safely given to children,
3> to study the pharmacokinetics (how your/your child's body breaks down and eliminates arsenic trioxide) by measuring the amount of drug in the bloodstream over time after a dose of arsenic trioxide,
4> to do various laboratory tests to see what changes arsenic trioxide causes in tumor cells during treatment.

Your/your child's treatment on this study is expected to last 6 to 18 weeks, depending on recovery from side effects and response to treatment. After treatment is over, your/your child's medical condition will be evaluated.

Patient Inclusion/Exclusion Criteria:

See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: July 16, 2008 at 2:47:12 PM