A Phase I Trial of the Immunostimulant JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
This is a Phase 1, open-label, dose escalation study of JVRS-100. The study will proceed in
2 stages to minimize the number of patients treated at doses substantially below the
recommended phase 2 dose. In stage 1, cohorts of three will be treated at each dose level
however doses will be doubled from level to level. Stage 2 will commence after a dose
limiting toxicity is observed in stage 1 or after the maximum dose for stage 1 is reached.
Stage 2 will follow a modified Fibonacci schema with 3-6 subjects at each dose level until a
recommended phase 2 dose is determined. The cohort will then be expanded to a maximum of 12
patients to more fully evaluate the recommended phase 2 dose. The Principal Investigator
will assign dose level to be administered to all patients.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability of JVRS-100
Toxicities will be assessed on day 30 of cycle 1. Establish dose limiting toxicity and a maximum tolerated dose recommended Phase 2 dose.
Day 30 of cycle #1
David F Claxton, MD
Milton S. Hershey Medical Center
United States: Food and Drug Administration
|Penn State Hershey Cancer Institute||Hershey, Pennsylvania 17033|