Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006095
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2000-08-03
Brief Title:
Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068102 | OTHER | Clinical Trialsgov | None |
| COG-P9971 | OTHER | None | None |
| CCG-P9971 | OTHER | None | None |
| POG-9971 | OTHER | None | None |