Protocol

ADV1014: A Phase I dose escalation study of REOLYSIN, a replication competent reovirus, in pediatric patients with relapsed or refractory solid tumors

Diseases

Solid Tumor : Recurrent solid tumors

Description

This is a phase I study of a virus called REOLYSIN. REOLSYIN has been developed from the naturally-occurring reovirus. Reovirus (Respiratory Enteric Orphan Virus) is a common virus that most people (70% to 100%) have been exposed to in their lifetime. REOLYSIN is considered experimental because it has not been approved by the Food and Drug Administration (FDA).

This is called a Phase I study because the goal is to find the highest dose of REOLYSIN that we can give safely. This Study focuses on REOLYSIN because it seems to work against cancer in test tubes and animals. The study team does not know if REOLYSIN will work in people. REOLYSIN is an unmodified virus that can make copies of itself inside the human body and possibly attack and destroy cancer cells. Because the patient’s body’s immune system might try to destroy the REOLYSIN, some participants enrolled later in the study will also take a drug called cyclophosphamide by mouth in an attempt to stop the body from destroying REOLYSIN. This will also help us find out if it is safe to give REOLYSIN and chemotherapy at the same time.

Objectives

• To find the highest safe dose of REOLYSIN that can be given without causing severe side effects;
• To learn what kind of side effects REOLYSIN can cause;
• To learn more about how the body handles (eliminates) the REOLYSIN;
• To learn more about the biology of REOLYSIN;
• To learn if REOLYSIN can be administered safely in combination with oral cyclophosphamide
• To determine whether REOLYSIN is a beneficial treatment for the patient’s tumor.

Eligibility

• Patient must be between greater than or equal to 3 years and less than or equal to 21 years of age at the time of study enrollment.
• Patients with relapsed or refractory solid tumors, with the exception of brain and spinal cord tumors and lymphomas, are eligible. Patients must have had a biopsy that demonstrated cancer at original diagnosis or relapse.
• All patients and/or their parents or legally authorized representatives must sign a written informed consent document.
• Pregnant or breast-feeding women will not be entered on this study due to risks of injury to the baby as seen in animal/human studies. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• Patients who are currently receiving another investigational drug or Anti-cancer agents or patients who have an uncontrolled infection are not eligible.
• Patients must have adequate bone marrow, kidney, heart, and liver function as outlines in the study in order to be eligible.

For the current eligibility status of this clinical study, referring physicians may contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Alberto Pappo, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
Fax: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.