drugset / Trial / NCT00186849
Therapy for Children With Advanced Stage High Risk Neuroblastoma
Phase 2
Completed
30 enrolled
St. Jude Children's Research Hospital
National Institutes of Health (NIH) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase II pilot study of chemotherapy and surgery for children with advanced stage high-risk neuroblastoma utilizing topotecan during an upfront window and other active agents during induction and intensification phases. The primary purpose is to estimate the response rate to an upfront window of two cycles of intravenous topotecan. We hypothesize that the topotecan window will be an effective therapy in terms of the response rate.
Timeline
- Start
- 1997-10
- Primary completion
- 2001-04
- Completion
- 2001-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 700 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 1 g | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 35 mg/m2 | — |
| Subject | Etoposide | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 250 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 2 g | Intravenous |
| Subject | Topotecan | Small molecule | 3 mg/m2 | Intravenous |