drugset
drugset / Trial / NCT01294670

Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors

NCT01294670 ↗

Phase 1/2 Completed 27 enrolled Memorial Sloan Kettering Cancer Center Alberta Children's Hospital · collabArnold Palmer Hospital for Children · collabChildren's Hospital Colorado · collabChildren's Mercy Hospital Kansas City · collabDana-Farber Cancer Institute · collabJohns Hopkins All Children's Hospital · collabJohns Hopkins University · collabM.D. Anderson Cancer Center · collabMerck Sharp & Dohme LLC · collabMilton S. Hershey Medical Center · collabPhoenix Children's Hospital · collabSidney Kimmel Comprehensive Cancer Center at Johns Hopkins · collabUniversity of Florida · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find out how safe and effective treatment with a new combination of drugs, vorinostat and etoposide, is in treating cancer. The medication etoposide is a standard medication used in the treatment of cancer in children. Vorinostat is an experimental drug which targets a protein(s) that control the way cancer cells grow and divide. Vorinostat is approved by the FDA in adults with certain cancers but not approved yet in children. There are two parts to this study. In the first part of this study, the phase I portion, a safe dose of the combination, vorinostat and etoposide. The goal of second part of this study, the phase II portion, is to see how effective the combination of vorinostat and etoposide is in treating cancer.

Timeline

Start
2011-02-09
Primary completion
2020-12-08
Completion
2020-12-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Vorinostat Small molecule 270 mg/m2 Oral

Indications

refractory malignant neoplasm