A Phase I Dose-escalation Trial of vvDD-CDSR (Double-deleted Vaccinia Virus Plus CD/ SMR) Administered by Intratumoral Injection or Intravenous Injection
This is a Phase I, open-label, single dose, dose-escalation trial in subjects with melanoma,
breast cancer, or head and neck squamous cell cancer, liver, colorectal or pancreatic
adenocarinoma. The intratumoral subjects will be stratified into 2 groups. Group A includes
those who have been vaccinated with vaccinia virus. A history of vaccination and a scar at
vaccination site is required. Group B subjects will include those who have not been
vaccinated. It is expected that the toxicity profile will be quite different between those
who have been vaccinated previously with vaccinia virus and therefore subjects will be
stratified separately in this Phase I trial. All subjects who have refractory tumors will
receive treatment at one of five dose levels in a single dose sequential dose-escalating
design. Eligible subjects will receive 1 treatment of vvDD-CDSR. A dose can be divided
between 1-3 lesions. The sum total of the maximal diameters of the lesion(s) to be injected
must be < 10cm.
Once the MTD and/or MFD has been defined in the vaccinated I.T. arm described above,
additional subject may be enrolled at one dose level lower than the MTD/MFD and the I.V.
infusion phase may begin. Patients enrolled in the IV infusion arm will receive a single
administration of vvDD-CDSR at one of three dose levels in a sequential dose-escalating
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximally tolerated dose (MTD) and/or maximum-feasible dose (MFD) and Safety of vvDD-CDSR administered by intratumoral (I.T.) injection and intravenous (I.V.) infusion.
Herbert J. Zeh, MD, PhD
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|