A Phase I Dose Escalation Study of Seneca Valley Virus (NTX-010), a Replication-Competent Picornavirus, in Relapsed/Refractory Pediatric Patients with Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors with Neuroendocrine Features

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Research

Protocol

ADV911: A Phase I Dose Escalation Study of Seneca Valley Virus (NTX-010), a Replication-Competent Picornavirus, in Relapsed/Refractory Pediatric Patients with Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors with Neuroendocrine Features

Diseases

Solid Tumor : Neuroblastoma, rhabdomyosarcoma, Wilms tumor, retinoblastoma, adrenocortical carcinoma and carcinoid tumor

Description

This is a phase I study of a virus called Seneca Valley Virus (NTX-010). NTX-010 is considered experimental because it has not been approved by the Food and Drug Administration (FDA). This study uses NTX-010 because it seems to work against cancer in test tubes and animals. This study does not guarantee if NTX-010 will work in people. NTX-010 has been used in only a small number of adults. NTX-010 is given in the hopes of finding a treatment that may be effective against recurrent tumors. The purpose of such studies (Phase I studies) is to find the highest dose of the drug that can be given safely to children and young adults, and to learn what its side effects are. The duration of the study will be for 22 months.

Objectives

To find the highest safe dose of NTX-010 that can be given without causing severe side effects;
To learn what kind of side effects NTX-010 can cause;
To learn more about how the body handles (eliminates) the NTX-010;
To learn more about the biology of NTX-010;
To determine whether NTX-010 is a beneficial treatment for these kinds of tumors.

Eligibility

Patient should be between 3 and 21 years of age.
Patients with primary recurrent or refractory neuroblastoma, rhabdomyosarcoma, Wilms tumor, retinoblastoma, adrenocortical carcinoma and carcinoid tumor
Pregnant or breast-feeding women will not be entered on this study due to risks of human fetal.
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 are not eligible.

For the current eligibility status of this clinical study, referring physicians must 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.

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