NCT02512926

Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children

Phase I Study of Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children With Relapsed and Refractory Solid Tumors and Leukemias

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 6 Months – 29 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the use of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed/refractory solid tumors or leukemia. The medications cyclophosphamide and etoposide are standard drugs often used together for the treatment of cancer in children with solid tumors or leukemia. Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults with multiple myeloma (a type of cancer). However, this drug is not approved to treat children with relapsed/refractory solid tumors or leukemia. With this research, we plan to determine the DLTs and MTD of Carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors.

Detailed description

Part 1 of the study will include a dose escalation based on Dose limiting toxicities (DLTs) until the MTD or highest dose level is reached, whichever comes first. At the MTD or highest dose level (if no MTD is reached), an additional 6 patients will be enrolled to further evaluate safety of the regimen (Part 2). Part 2 of this study will enroll additional patients at the highest tolerable dose found in Part 1 in order to get more information on side effects and make sure the dose is tolerable Once an MTD is determined for Strata A or B, if the Study Principal Investigator determines that the study treatment should not be further pursued due to safety or enrollment barriers, the expansion Part or the study will be discontinued.

Conditions

• Relapsed Solid Tumors
• Refractory Solid Tumors
• Relapsed Leukemia
• Refractory Leukemia

Interventions

Type	Name	Description
DRUG	Carfilzomib	Carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias
DRUG	Cyclophosphamide
DRUG	Etoposide

Timeline

• Start date: 2016-02-16
• Primary completion: 2021-08-28
• Completion: 2023-11-07
• First posted: 2015-07-31
• Last updated: 2025-10-15

Locations

8 sites across 2 countries: United States, Canada