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Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00625456
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
SillaJen, Inc. ( Jennerex Biotherapeutics )

Study Description
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Brief 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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion [ Time Frame: 4 weeks ]
  2. 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 :
  1. Determine the JX-594 pharmacokinetics and pharmacodynamics over time following IV infusion [ Time Frame: 4 weeks ]
  2. Determine the immune response to JX-594 following IV infusion [ Time Frame: 4 weeks ]
  3. Determine the delivery of JX-594 to, and concentration within, solid tumors following IV infusion [ Time Frame: 4 weeks ]

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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625456


Locations
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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
Investigators
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Study Director: David Kirn, MD Jennerex Inc.
More Information
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Responsible Party: Jennerex Biotherapeutics
ClinicalTrials.gov Identifier: NCT00625456    
Other Study ID Numbers: JX594-IV-011
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: March 2012
Keywords provided by SillaJen, Inc. ( Jennerex Biotherapeutics ):
phase I
advanced metastatic solid tumors
oncolytic virus
vaccinia virus
melanoma
 lung cancer
renal cell carcinoma
squamous cell carcinoma of the head and neck
Pexa-Vec
Additional relevant MeSH terms:
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Vaccinia
Carcinoma
Melanoma
Carcinoma, Squamous Cell
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Neoplasms, Squamous Cell
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Head and Neck Neoplasms
Poxviridae Infections
DNA Virus Infections
Virus Diseases