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Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
SillaJen, Inc. ( Jennerex Biotherapeutics ) Identifier:
First received: February 19, 2008
Last updated: November 30, 2015
Last verified: March 2012
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.

Condition Intervention Phase
Melanoma Lung Cancer Renal Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus Plus GM-CSF) Administered by Intravenous Infusion in Patients With Refractory Solid Tumors

Resource links provided by NLM:

Further study details as provided by SillaJen, Inc. ( Jennerex Biotherapeutics ):

Primary Outcome Measures:
  • Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion [ Time Frame: 4 weeks ]
  • Safety/Toxicity: Incidence of treatment-related adverse events; treatment-related serious adverse events; treatment-related Grade 3/4 toxicities; and clinically-significant, treatment-related changes from baseline in routine laboratory parameters [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Determine the JX-594 pharmacokinetics and pharmacodynamics over time following IV infusion [ Time Frame: 4 weeks ]
  • Determine the immune response to JX-594 following IV infusion [ Time Frame: 4 weeks ]
  • Determine the delivery of JX-594 to, and concentration within, solid tumors following IV infusion [ Time Frame: 4 weeks ]

Enrollment: 23
Study Start Date: June 2008
Study Completion Date: June 2014
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm, dose escalation
dose escalation starting dose 1e5 pfu/kg bw to 3e7 pfu/kg bw; Recombinant Vaccinia GM-CSF (JX-594)
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
Other Name: JX-594


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically-confirmed, advanced/metastatic solid tumor refractory to standard therapy or the patient has refused or does not tolerate the standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck
  • At least one measurable tumor mass by CT/MRI (i.e. lesion that can accurately be measured in at least one dimension with longest diameter > 1 cm)
  • At least one tumor mass amenable to biopsy and/or FNA
  • Expected survival for approximately 16 weeks or longer
  • Karnofsky Performance Score (KPS) ≥ 70
  • Age ≥18 years
  • WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3
  • ANC ≥ 1,500 cells/mm3
  • Hemoglobin ≥ 10 g/dL
  • Platelet count ≥ 100,000 plts/mm3
  • Total bilirubin ≤ 1.5 x ULN
  • AST, ALT ≤ 2.5 x ULN
  • Serum chemistries within normal limits (WNL) or Grade 1 - If patients are diabetic or have a screening random glucose > 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study.
  • Acceptable coagulation status: INR ≤ (ULN + 10%)
  • CD4 count ≥ 500/mm3

Exclusion Criteria:

  • Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
  • Known myeloproliferative disorders requiring systemic therapy
  • History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy
  • Tumor(s) invading a major vascular structure (e.g. carotid artery)
  • Tumor(s) in location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur (e.g. tumors impinging on the upper airway or affecting biliary tract drainage, etc.)
  • Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
  • Severe or unstable cardiac disease
  • Current, known CNS malignancy (history of completely resected or irradiated brain metastases allowed)
  • Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
  • Use of anti-viral, anti-platelet, or anti-coagulation medication [Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.]
  • Pulse oximetry O2 saturation <90% at rest
  • Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination

Household contact exclusions:

  • Women who are pregnant or nursing an infant
  • Children < 5 years old
  • History of exfoliative skin condition (e.g. eczema) that at some stage has required systemic therapy
  • Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00625456

United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
Canada, Ontario
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Jennerex Biotherapeutics
Study Director: David Kirn, MD Jennerex Inc.
  More Information

Responsible Party: Jennerex Biotherapeutics Identifier: NCT00625456     History of Changes
Other Study ID Numbers: JX594-IV-011
Study First Received: February 19, 2008
Last Updated: November 30, 2015

Keywords provided by SillaJen, Inc. ( Jennerex Biotherapeutics ):
phase I
advanced metastatic solid tumors
oncolytic virus
vaccinia virus
lung cancer
renal cell carcinoma
squamous cell carcinoma of the head and neck

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma, Renal Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases processed this record on September 21, 2017