drugset / Trial / NCT00808899
Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma
NaSingle-groupOpen-labelTreatment
Summary
A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed by and additional six courses of induction chemotherapy and then intensification with autologous hematopoietic stem cell transplantation. The first five courses of induction chemotherapy will also evaluate the feasibility of combining weekly temsirolimus with these standard chemotherapy combinations. This will be followed by 16 months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight months of oral topotecan.
Timeline
- Start
- 2008-12
- Primary completion
- 2009-07
- Completion
- 2009-07
Outcome
Outcome not reported
Stopped: “Voluntarily closed and terminated by the PI due to lack of feasibility”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 15 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Temsirolimus | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Temsirolimus | Small molecule | 50 mg/m2 | Intravenous |
| Background | 13-cis-retinoic acid | Unknown | — | Oral |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Etoposide | Small molecule | — | — |
| Background | Topotecan | Small molecule | — | Oral |