CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Vorinostat and Etoposidedrug
Likely dose
Vorinostat and Etoposide 270 mg/m2from record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01294670
NCT01294670Phase 2Completed
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A Phase I/II Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors

Memorial Sloan Kettering Cancer Center·interventional·Posted Feb 11, 2011·Updated Nov 18, 2021

In Brief

A Phase 2 clinical trial evaluating Vorinostat and Etoposide for Solid Tumors and Relapsed/Refractory Sarcomas. Completed, enrolled 27 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors, Relapsed/Refractory Sarcomas
CountriesCanada, United States
CollaboratorsMerck Sharp & Dohme LLC, Phoenix Children's Hospital, Milton S. Hershey Medical Center, Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Children's Hospital Colorado, University of Florida, Alberta Children's Hospital, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute, Children's Mercy Hospital Kansas City, Johns Hopkins All Children's Hospital, Arnold Palmer Hospital for Children

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2011
Enrollment StartFeb 9, 2011
Primary CompletionDec 8, 2020
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 15.4 years ago

Interventions

Vorinostat and Etoposidedrug

Patients will be assessed in 3-week cycles. Escalating doses of vorinostat will be administered orally on a daily x 4 schedule in combination with a fixed dose of etoposide. Etoposide will be administered intravenously daily x 3 days. Cohorts of 3-6 patients will be treated with vorinostat and etoposide. In the phase II component, patients will be treated at the RP2D established in the Phase I component of the study, which was found to be 270 mg/m2/dose of Vorinostat and 100 mg/m2/dose of Etoposide.