drugset / Trial / NCT02390843
Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I trial with new experimental drugs such as simvastatin in combination with topotecan and cyclophosphamide in the hopes of finding a drug that may work against tumors that have come back or that have not responded to standard therapy. This study will define toxicity of high dose simvastatin in combination with topotecan and cyclophosphamide and evaluate for cholesterol levels and IL6/STAT3 pathway changes as biomarkers of patient response.
Timeline
- Start
- 2015-02
- Primary completion
- 2019-09-22
- Completion
- 2019-09-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simvastatin | Small molecule | 100 mg/m2 | Oral |
| Subject | Simvastatin | Small molecule | 140 mg/m2 | Oral |
| Subject | Simvastatin | Small molecule | 180 mg/m2 | Oral |
| Subject | Simvastatin | Small molecule | 225 mg/m2 | Oral |
| Subject | Simvastatin | Small molecule | 290 mg/m2 | Oral |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | Intravenous |
| Background | Granulocyte colony-stimulating factor (G-CSF) | Unknown | — | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | Topotecan | Small molecule | 0.75 mg/m2 | Intravenous |