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JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia

Leukemia Clinical Trial

Official title:
A Phase I Trial of the Immunostimulant JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia

Clinical Trial Summary

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, an accelerated titration schema will be followed with one patient at each dose 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00860522
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Completed
Phase Phase 1
Start date March 1, 2009
Completion date February 20, 2017
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