Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma

Phase 2 Completed 59 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma.

Timeline

Start: 2006-04
Primary completion: 2009-03
Completion: 2013-12

Outcome

Mixed primary results

paper Of the first 25 evaluable patients on a given stratum, five or more patients with complete or partial responses were required PMID 21115869 ↗

paper Objective responses were observed in three of the first 25 evaluable patients on stratum 1 and five of the first 25 evaluable patients on stratum 2. PMID 21115869 ↗

Publications

Results Bagatell R, London WB, Wagner LM, Voss SD, Stewart CF, Maris JM, Kretschmar C, Cohn SL. Phase II study of irinotecan and temozolomide in children with relapsed or refractory neuroblastoma: a Children's Oncology Group study. J Clin Oncol. 2011 Jan 10;29(2):208-13. doi: 10.1200/JCO.2010.31.7107. Epub 2010 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	10 mg/m2	Intravenous
Subject	Temozolomide	Small molecule	100 mg/m2	Intravenous