Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Children's Oncology Group
With
OBJECTIVES: * Determine the maximum tolerated dose and dose limiting toxicity of vincristine when administered in combination with irinotecan in children with refractory solid tumors. * Determine the safe and tolerable phase II dose of this combination regimen in this patient population. * Determine the pharmacokinetics of this combination regimen in these patients. * Determine the incidence and severity of other toxicities of this combination regimen in these patients. * Determine preliminary evidence of antitumor activity of this combination regimen in this patient population. OUTLINE: This is a dose-escalation study of vincristine. Patients receive vincristine IV on day 2 of the first course (day 1 of subsequent courses) and days 8, 15, 22, and 29, and irinotecan IV over 1 hour on days 1-5 and 22-26. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease receive additional courses of therapy for a maximum of 1 year. Cohorts of 3-6 patients receive escalating doses of vincristine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
