Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062842
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2003-06-17
Brief Title:
Study of Irinotecan on a Weekly Schedule in Children
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Pediatric Phase I and Pharmacokinetic Study of Irinotecan
Status:
COMPLETED
Status Verified Date:
2020-03
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 medicine being offered in this study is called Irinotecan Irinotecan has been effective against many animal cancers It has been given to both adults and children We are now attempting to determine how much of the drug can be given to children when Irinotecan is given weekly for four weeks in a row every 6 weeks and the toxicities bad side effects that occur when irinotecan is administered on this schedule
The purposes of this study are to
1 To determine the highest dose of Irinotecan that can safely be given to children whose cancer no longer responds to standard treatment
2 To determine the toxicities of Irinotecan
3 To determine what studies laboratory or x-rays need to be done to evaluate the toxicities of this drug
4 To determine if irinotecan is beneficial to the patient
5 To understand how the drug Irinotecan works in the body
The purposes of this study are to
1 To determine the highest dose of Irinotecan that can safely be given to children whose cancer no longer responds to standard treatment
2 To determine the toxicities of Irinotecan
3 To determine what studies laboratory or x-rays need to be done to evaluate the toxicities of this drug
4 To determine if irinotecan is beneficial to the patient
5 To understand how the drug Irinotecan works in the body
Detailed Description:
Irinotecan will be given intravenously into the vein over 90 minutes for four weeks in a row This cycle may be repeated in six weeks as long as the cancer is not getting worse and there are no serious side effects
After one cycle patients will be evaluated to decide if the treatments should continue If the disease is no worse or better additional courses may be given If treatment continues evaluations will be done after the second cycle and then every 2 cycles
If patients choose to participate in this study we would request that they remain in the study for one full cycle During the first cycle of treatment we would like to draw special blood samples to help us learn how much drug is in the blood These special studies are called pharmacokinetics On the first day the drug is given fourteen blood samples will be drawn Each blood sample will be about 12 teaspoon for a total of about 3 tablespoons These samples will only be drawn during the first cycle of therapy The total amount of blood drawn will be less than 5 of the total blood volume an amount safe even for small children
Examinations and other blood tests will be done twice a week initially then weekly to look for side effects of the drug Patients will have an additional one teaspoon of blood drawn at each of these visits
After one cycle patients will be evaluated to decide if the treatments should continue If the disease is no worse or better additional courses may be given If treatment continues evaluations will be done after the second cycle and then every 2 cycles
If patients choose to participate in this study we would request that they remain in the study for one full cycle During the first cycle of treatment we would like to draw special blood samples to help us learn how much drug is in the blood These special studies are called pharmacokinetics On the first day the drug is given fourteen blood samples will be drawn Each blood sample will be about 12 teaspoon for a total of about 3 tablespoons These samples will only be drawn during the first cycle of therapy The total amount of blood drawn will be less than 5 of the total blood volume an amount safe even for small children
Examinations and other blood tests will be done twice a week initially then weekly to look for side effects of the drug Patients will have an additional one teaspoon of blood drawn at each of these visits
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