Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma
All children will receive fixed doses of intravenous temsirolimus (50 mg/m2 weekly 6 times )
concomitantly with two courses of fixed dosages of irinotecan (20 mg/m2 intravenously daily
5 times ,2 days off, repeated daily 5 times .If these initial dosages are not tolerable then
subsequent patients will be given a reduced dosage of temsirolimus (25 mg/m2 weekly 6 times)
with 20 mg/m2 of irinotecan.If this dosage combination is not tolerable, the irinotecan
dosage will be decreased to 15 mg/m2 .If this dosage combination is not tolerable then
further enrollment to the initial six week treatment will be terminated.The second course of
irinotecan will begin on day 22 and response will be determined after six weeks (two
courses). Resection of primary tumor will be attempted after this initial therapy, whenever
possible.
Following initial treatment children will undergo alternating courses of induction
chemotherapy with cyclophosphamide, doxorubicin, etoposide, topotecan, and cisplatin (Block
2). The first cohort of 17 patients will receive Block 2 with temsirolimus (50mg/m2) for all
three courses, weekly 2 times. If this is not tolerated subsequent patients will receive
Block 2 chemotherapy with reduced dosages of temsirolimus (25mg/m2).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response Plus Partial Response
The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.
10 years
Yes
Wayne L Furman, MD
Principal Investigator
St. Jude Children's Research Hospital
United States: Food and Drug Administration
NB2008
NCT00808899
December 2008
July 2009
Name | Location |
---|---|
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |