Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

September 22, 2019

Study Completion Date

September 22, 2019

Conditions
RetinoblastomaClear Cell SarcomaRenal Cell CarcinomaRhabdoid TumorWilms TumorHepatoblastomaNeuroblastomaGerm Cell TumorsEwings SarcomaNon-rhabdomyosarcoma Soft Tissue SarcomaOsteosarcomaRhabdomyosarcoma
Interventions
DRUG

Simvastatin

The starting dose of simvastatin will be 140 mg/m\^2/dose BID for 21 days for the first group. Dose escalation for subsequent groups will be 180 mg/m\^2/dose BID, 225 mg/m\^2/dose BID, and 290 mg/m\^2/dose BID. If the maximum tolerated dose (MTD) has been exceeded at the first dose level, then the subsequent cohort of subjects will be treated at a dose of 100 mg/m2/dose BID (dose level 0). Simvastatin will be administered orally twice daily, approximately 12 hours apart. Feeding tube (nasogastric tube or gastrostomy tube, NOT a jejunum localized tube) administration is allowed. If a subject vomits a dose of simvastatin, it will not be repeated.

DRUG

Cyclophosphamide

The dose of cyclophosphamide will be fixed at 250 mg/m\^2/dose. Cyclophosphamide will be administered intravenously over 30 minutes once daily for 5 days every 21 days.

DRUG

Topotecan

The dose of topotecan will be fixed at 0.75 mg/m\^2/dose. Topotecan will be administered, after cyclophosphamide, intravenously over 30 minutes once daily for 5 days every 21 days.

DRUG

Myeloid growth factor

Myeloid growth factor (G-CSF or pegylated G-CSF) will be initiated 24-48 hours after the completion of topotecan and cyclophosphamide for all subjects, which would be day 6 or 7. Myeloid growth factor should continue until the absolute neutrophil count is greater than 2,000/mm\^3

Trial Locations (1)

30322

Children's Healthcare of Atlanta/Emory University, Atlanta

Sponsors
All Listed Sponsors
collaborator

Children's Healthcare of Atlanta

OTHER

lead

Emory University

OTHER