Sirolimus With Cyclophosphamide and Topotecan for Pediatric/Adolescent Relapsed and Refractory Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
Malignant Solid TumorChildhood Solid Tumor
Interventions
DRUG

Sirolimus, Cyclophosphamide, Topotecan

Dosing of cyclophosphamide and topotecan will be 25 mg/m2/dose and 0.8 mg/ m2 /dose respectively for dose levels 1 and 2. Level 3 dosing will escalate cyclophosphamide to 50 mg/ m2/dose. If level 1 dosing not tolerated, patients will be enrolled in level -1 cohort with cyclophosphamide and sirolimus administered only on days 1-14. If level -1 not tolerated, patients will be enrolled in level -2 with topotecan administration limited to days 1-7.

Trial Locations (1)

94143

UCSF Benioff Children's Hospital, San Francisco

All Listed Sponsors
collaborator

Hyundai Hope On Wheels

OTHER

lead

University of California, San Francisco

OTHER

NCT01670175 - Sirolimus With Cyclophosphamide and Topotecan for Pediatric/Adolescent Relapsed and Refractory Solid Tumors | Biotech Hunter | Biotech Hunter