Please read the information below for Dr. Cripe’s HSV1716 study. Please feel free to contact Melinda Lynn (see below) if you need additional information.


Clinical Study for Children and Adults 7 to 30 Years Old With Refractory Non-CNS Solid Tumors

What:
This is a phase I dose escalation study of intratumoral or intravenous herpes simplex virus-1 mutant HSV1716 in subjects with refractory non-central nervous system solid tumors.

Investigational Product:

  • HSV1716, an oncolytic virus that replicates in and lyses the dividing cells of tumors but fails to replicate in normal post-mitotic cells
  • Administered via intratumoral or intravenous injection

Objectives:

  • Determine safety of intratumoral or intravenous injection of HSV1716
  • Measure antiviral immune response
  • Measure systemic viremia following i HSV1716 administration
  • Measure antitumor activity (within the confines of a Phase I study)

Main Inclusion Criteria:

  • Progressive or refractory non-CNS solid tumor for which no curative therapy is known
  • Subjects with inactive metastasis to the brain are eligible but no CNS sites will be injected
  • Must have fully recovered from side effects of all prior treatment
  • Age ≥7 and ≤30 years at time of consent

Main Exclusion Criteria:V

  • > 4 weeks after use of an unlicensed or investigational product
  • Prior allogeneic hematopoietic stem cell transplant
  • GVHD subsequent to autologous stem cell transplant
  • Leukemia

Study Location:
Nationwide Children’s Hospital
700 Children’s Drive
Columbus, OH 43205

Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue
Cincinnati, OH 45229

20140203 - New Phase 1 Clinical Trial - Dr. Timothy Cripe, Nationwide Children's Hospital

Principal Investigator:
Timothy Cripe, MD, PhD (Nationwide Children’s Hospital)
James Gellar, MD (Cincinnati Children’s Hospital Medical Center)

For More Information:
Contact Melinda Lynn at Melinda.lynn@nationwidechildrens.org or 614-722-6039 or Dr. Timothy Cripe at timothy.cripe@nationwidechildrens.org or 614-722-3552

Contact Laura Fossett at cancer@cchmc.org or 513-636-2799 or Dr. James Gellar at james.gellar@cchmc.org or 513-636-4266