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Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors

NCT00625456 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-12-03

No results posted yet for this study

Summary

This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. These tumor types were selected because evidence of biological activity was observed in these tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in patients with metastatic disease to the liver. Patients will receive treatment at one of five dose levels in a sequential dose-escalating design.

Conditions

Interventions

DRUG

Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Intravenous Dosage from 1 x 10\^5 pfu/kg to 3 x 10\^7 pfu/kg Intravenous infusion is administered once over a 60 minute period

Sponsors & Collaborators

  • Jennerex Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • David Kirn, MD · Jennerex Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-04-30
Completion
2014-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625456 on ClinicalTrials.gov