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Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors

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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 )

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 28, 2008
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE June 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00625456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Lung Cancer
  • Renal Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Single Arm, dose escalation
dose escalation starting dose 1e5 pfu/kg bw to 3e7 pfu/kg bw; Recombinant Vaccinia GM-CSF (JX-594)
Intervention: Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2012)
23
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2008)
24
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625456
Other Study ID Numbers  ICMJE JX594-IV-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SillaJen, Inc. ( Jennerex Biotherapeutics )
Study Sponsor  ICMJE Jennerex Biotherapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Kirn, MD Jennerex Inc.
PRS Account SillaJen, Inc.
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP