A Phase I/II Clinical Study of Vorinostat Plus Etoposide in Pediatric Patients with Refractory Solid Tumors

Protocol
10-096
Full Title
A Phase I/II Clinical Study of Vorinostat in Combination with Etoposide in Pediatric Patients < 21 Years at Diagnosis with Refractory Solid Tumors
Phase
I/II
Purpose

The purpose of this study is to evaluate the safety and effectiveness of the combination of two drugs — vorinostat and etoposide — in children with malignant solid tumors that continue to grow despite standard therapy or for which no standard therapy exists.

Etoposide is a commonly used chemotherapy drug. Vorinostat is approved to treat a certain type of lymphoma in adults, but its use in children is considered investigational. Vorinostat is a capsule that is taken by mouth; etoposide is given intravenously (by vein).

Vorinostat is a drug called a histone deacetylase (HDAC) inhibitor. It prevents cancer cells from reproducing by interfering with certain signaling pathways.

In the phase I portion of this study, researchers will determine the highest safe dose of vorinostat that can be used in children. In the phase II portion of the study, they will evaluate this dose of vorinostat in combination with etoposide.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients with malignant solid tumors that continue to grow despite standard therapy or for which no standard therapy exists are eligible for the phase I portion. For the phase II portion, patients must have a solid tumor that has returned or stopped responding to standard treatment.
  • Patients must have been between the ages of 4 and 21 at the time of the initial diagnosis.
  • At least 2 weeks must have passed since completion of prior therapies and entry into the study, and patients must have recovered from any side effects.
  • Patients may not have had prior treatment with an HDAC inhibitor.

For more information about this study and to inquire about eligibility, please contact Dr. Tanya Trippett at 212-639-8267.

Locations