-transparent.png){kind=logo}
BACKGROUND The objectives of this study were to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), pharmacokinetics, and anti-tumor effect of irinotecan in pediatric patients with recurrent or refractory malignancies. METHODS Twenty-three patients between 1 and 21 years of age, with a solid tumor refractory to standard therapy or for which there was no standard therapy were enrolled. Irinotecan was administered over 90 min weekly 4x, every 6 weeks. The initial dose level was 125 mg/m(2)/day, with subsequent escalations to 160 and 200 mg/m(2)/day. A MTD was defined in heavily-pretreated and less-heavily-pretreated (< or =2 prior chemotherapy regimens, no prior bone marrow transplantation, and no central axis radiation) patients. Pharmacokinetic studies were also performed. RESULTS Neutropenia and diarrhea were the DLTs in heavily pretreated patients; the MTD was 125 mg/m(2)/day. Neutropenia was the DLT in less-heavily pretreated; the MTD was 160 mg/m(2)/day. Five patients had stable disease for two to four cycles including one patient each with rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, and two patients with ependymoma. Irinotecan clearance was greater that that previously reported for children receiving high dose irinotecan. CONCLUSIONS The recommended phase II dose of irinotecan administered weekly 4x, every 6 weeks in children with solid tumors is 125 mg/m(2)/dose for heavily pretreated patients and 160 mg/m(2)/dose for less heavily pretreated patients.
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
August 1994,
Cancer research,
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
January 1981,
Cancer treatment reports,
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
July 2005,
Cancer chemotherapy and pharmacology,
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
January 1993,
European journal of cancer (Oxford, England : 1990),
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
February 1990,
Investigational new drugs,
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
July 1976,
Cancer treatment reports,
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
December 2016,
Investigational new drugs,
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
January 1990,
Selective cancer therapeutics,
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
July 1992,
Gan to kagaku ryoho. Cancer & chemotherapy,
L Bomgaars, and
J Kerr, and
S Berg, and
J Kuttesch, and
R Klenke, and
S M Blaney
March 1987,
Cancer treatment reports,
