Pediatric Phase I and Pharmacokinetic Study of Irinotecan
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 1/2 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
H6957
NCT00062842
November 1998
May 2005
Name | Location |
---|---|
Texas Children's Hospital | Houston, Texas |