Research

Neuroblastoma, Rhabdomyosarcoma and Rare Tumor Treatment with NTX-010 – 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

Protocol Description

This Children’s Oncology Group Phase I trial is studying the side effects and best dose of Seneca Valley virus-001 (NTX-010) in treating young patients with relapsed or refractory neuroblastoma, rhabdomyosarcoma, or rare tumors with neuroendocrine features. Researchers believe that NTX-010 may be able to kill certain kinds of tumor cells without damaging normal cells.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, ages 3 to 21, who have been diagnosed with neuroblastoma, rhabdomyosarcoma, Wilms tumor, retinoblastoma, adrenocortical carcinoma or carcinoid tumor that has come back (relapsed) or has been resistant to treatment (refractory) or for which there is no known curative therapy.
Males: Ages 3 to 21 years
Females: Ages 3 to 21 years

Requirements
Participants will be provided a single 1-hour intravenous infusion of NTX-010 on the second visit, which is one week after the initial blood sample is taken. Thereafter, participation in the study involves blood monitoring to determine level of NTX-010 in the body. There will be four groups of participants, with NTX-010 dose levels increased successively for each of the last three groups.
Frequency of visits: 1 to 2 times a week for blood testing
Duration: About 7 weeks, with patients followed until evidence indicates no presence of NTX-010 in the body

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ADVL0911)
National Cancer Institute

Additional Resources
Study Description at National Institutes of Health