Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT00006095
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2000-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
Sponsor:
Children's Oncology Group
Organization:
Study Overview
Official Title:
A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: