NCT00006095

Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy

A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating children who have solid tumors that have not responded to previous therapy.

Detailed description

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.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride
DRUG	vincristine sulfate

Timeline

• Start date: 2000-07-01
• Primary completion: 2005-01-01
• Completion: 2005-09-01
• First posted: 2003-05-22
• Last updated: 2014-02-21

Locations

22 sites across 2 countries: United States, Australia