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

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unspecified Childhood Solid Tumor, Protocol Specific

• NCT number: NCT00006095
• Study type: Interventional
• Source: Children's Oncology Group
• Status: Completed
• Phase: Phase 1
• Start date: July 2000
• Completion date: September 2005