Spots Global Cancer Trial Database for Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
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Trial Identification
Brief Title: Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
Official Title: A Phase 1 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
Study ID: NCT01048892
Study Description
Brief Summary: RATIONALE: Seneca Valley virus-001 may be able to kill certain kinds of tumor cells without damaging normal cells. Adding low dose cyclophosphamide (in part B of study) may help to kill even more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of Seneca Valley virus-001 in treating young patients with relapsed or refractory neuroblastoma, rhabdomyosarcoma, or rare tumors with neuroendocrine features.
Detailed Description: OBJECTIVES: Primary * To estimate the maximum-tolerated dose and/or recommended phase II dose of Seneca Valley virus-001 (NTX-010) when administered as a single infusion to pediatric patients with relapsed or refractory neuroblastoma, rhabdomyosarcoma, or rare tumors with neuroendocrine features (Wilms tumor, retinoblastoma, adrenocortical carcinoma, or carcinoid tumors). (Part A \[completed\]) * To confirm that there is viral replication in these patients following NTX-010 administration. (Part A \[completed\]) * To define and describe the toxicities of NTX-010 when administered on this schedule. (Part A \[completed\]) * To determine whether the number of regulatory T cells (as measured by flow cytometry) can effectively be reduced following administration of NTX-010 plus low-dose metronomic and intravenous cyclophosphamide. (Part B) * To characterize the pharmacokinetics (time course of viral clearance) following NTX-010 administration in these patients. Secondary * To preliminarily define the antitumor activity of NTX-010 within the confines of a phase I study. (Part A \[completed\]) * To evaluate the development of neutralizing antibodies to NTX-010 following IV administration of NTX-010. (Part A \[completed\]) * To evaluate development of neutralizing antibodies to NTX-010 following the combination of NTX-010 and cyclophosphamide. (Part B) * To investigate the presence and permissivity of occult circulating tumor cells prior to and after the initial intravenous administration of NTX-010. OUTLINE: This is a multicenter study. Part A (completed): Patients receive Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1. Part B: Patients receive cyclophosphamide IV orally (PO) on days 1-14 and NTX-010 IV over 1 hour on day 8. In the absence of disease progression or unacceptable toxicity, patients then receive cyclophosphamide orally (PO) on days 22-35, plus cyclophosphamide IV over 1 hour and NTX-010 IV over 1 hour on day 29. Tumor tissue samples are collected at baseline for biomarker studies. Blood and stool samples are collected periodically for neutralizing antibody and viral clearance studies. Additional blood samples may also be collected for the presence and permissivity of occult tumor cells. After completion of study treatment, patients are followed up periodically for up to 1 year.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
Riley's Children Cancer Center at Riley Hospital for Children, Indianapolis, Indiana, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Michael J. Burke, MD
Affiliation: Masonic Cancer Center, University of Minnesota
Role: STUDY_CHAIR
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