Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT00143533
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Phase I Study of Intravenous Irinotecan Using Selective Gastrointestinal Decontamination for Prevention of Diarrhea in Relapsed or Refractory Pediatric Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-09
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:
The primary purpose of this study is to estimate the maximum tolerated dose of irinotecan with the use of cefpodoxime for pediatric solid tumor patients.
Detailed Description:
This is a phase I study with the exploratory investigation of at least four dosage levels (20, 30, 45, 60) to define the tolerable dose for phase II studies. Primary consideration will be given to determinations of the qualitative and quantitative toxicity of the administration of irinotecan with cefpodoxime, and pharmacokinetics of irinotecan when given with cefpodoxime.
Standard phase I escalation study in cohorts of 3-6 patients. Starting level is 20 mg/m2/d, and subsequent levels will be 30 mg/m2/d, 45 mg/m2/d and 60 mg/m2/d. An amendment to the study has included an intermediate level at 40 mg/m2/d.
Irinotecan will be administered as a 60-minute intravenous infusion daily for 5 consecutive days, followed by a 2 day rest, and followed by an additional 5 consecutive days course \[(qd x 5) x 2\]. Twenty-one days from the first dose will be considered one cycle of therapy. Cefpodoxime will be given orally at 10 mg/kg/day divided BID, starting 2 days prior to the beginning of the first course of irinotecan, and will be continued for the duration of study participation.
Additional objectives include:
* To describe the pharmacokinetics of intravenous irinotecan when given with oral cefpodoxime.
* To describe the dose-limiting toxicity/ies of irinotecan given on the \[(qd x 5) x 2\] with oral cefpodoxime.
* To evaluate the effect of the administration of oral cefpodoxime on the amount of intestinal beta-glucuronidase.
* To correlate the incidence and severity of diarrhea with the amount of intestinal beta-glucuronidase.
* To describe the toxicities of irinotecan given at doses above 20 mg/m2/d
* To note tumor responses within the confines of a phase I trial
Standard phase I escalation study in cohorts of 3-6 patients. Starting level is 20 mg/m2/d, and subsequent levels will be 30 mg/m2/d, 45 mg/m2/d and 60 mg/m2/d. An amendment to the study has included an intermediate level at 40 mg/m2/d.
Irinotecan will be administered as a 60-minute intravenous infusion daily for 5 consecutive days, followed by a 2 day rest, and followed by an additional 5 consecutive days course \[(qd x 5) x 2\]. Twenty-one days from the first dose will be considered one cycle of therapy. Cefpodoxime will be given orally at 10 mg/kg/day divided BID, starting 2 days prior to the beginning of the first course of irinotecan, and will be continued for the duration of study participation.
Additional objectives include:
* To describe the pharmacokinetics of intravenous irinotecan when given with oral cefpodoxime.
* To describe the dose-limiting toxicity/ies of irinotecan given on the \[(qd x 5) x 2\] with oral cefpodoxime.
* To evaluate the effect of the administration of oral cefpodoxime on the amount of intestinal beta-glucuronidase.
* To correlate the incidence and severity of diarrhea with the amount of intestinal beta-glucuronidase.
* To describe the toxicities of irinotecan given at doses above 20 mg/m2/d
* To note tumor responses within the confines of a phase I trial
Study Oversight
Has Oversight DMC:
False
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?: