Carfilzomib + Cyclophosphamide + Etoposide for Pediatric Cancer (POE14-01 Trial)

Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Children aged 6 months to nearly 30 years with relapsed/refractory leukemia or solid tumors, who have recovered from previous treatments and have a life expectancy of at least 3 months. They must not be pregnant, breastfeeding, or have certain diseases like Fanconi Anemia or active infections.

Treatment Details

The trial is testing the effectiveness of carfilzomib combined with standard cancer drugs cyclophosphamide and etoposide in children whose cancer has returned or didn't respond to treatment. The goal is to find the safest dose that can manage these cancers.

1Treatment groups

Experimental Treatment

Group I: CarfilzomibExperimental Treatment3 Interventions

Carfilzomib in combination with cyclophosphamide and etoposide

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Kyprolis for: