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

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.

Conditions

• Solid Tumors
• Relapsed/Refractory Sarcomas

Interventions

DRUG

Vorinostat and Etoposide

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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Phoenix Children's Hospital

  collaborator OTHER

• Milton S. Hershey Medical Center

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Alberta Children's Hospital

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Children's Mercy Hospital Kansas City

  collaborator OTHER

• Johns Hopkins All Children's Hospital

  collaborator OTHER

• Arnold Palmer Hospital for Children

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Tanya Trippett, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

4 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-09

Primary Completion

2020-12-08

Completion

2020-12-08

Countries

• United States
• Canada

Study Locations