drugset
drugset / Trial / NCT00135135

Therapy for Children With Neuroblastoma

NCT00135135 ↗

Phase 2 Completed 23 enrolled St. Jude Children's Research Hospital AstraZeneca · collabNational Institutes of Health (NIH) · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy, intensification with autologous stem cell transplantation, and an oral maintenance phase with 13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan window will be efficacious.

Timeline

Start
2005-08
Primary completion
2007-06
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 112.5 mg/m2 Oral
Subject Irinotecan Small molecule 15 mg/m2 Intravenous
Subject Topotecan Small molecule 0.06 mg/kg Intravenous
Subject Topotecan Small molecule 1.8 mg/m2 Intravenous
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified 40 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 1500 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Etoposide Small molecule 30 mg/m2 Intravenous
Background Etoposide Small molecule 200 mg/m2 Intravenous
Background Etoposide Small molecule 250 mg/m2 Intravenous
Background Isotretinoin Other / unclassified 5.33 mg/kg Oral
Background Isotretinoin Other / unclassified 160 mg/m2 Oral
Background Melphalan Small molecule 45 mg/m2 Intravenous

Indications

neuroblastoma